MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Initial reporter occupation: clinical products advisor.Pma/510(k) #: k950118.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient had a single lumen peripherally inserted central venous catheter set inserted on (b)(6) 2021 for delivering antibiotic therapy and crystalloid iv fluid administration.The device was secured with a securement device.On (b)(6) 2021, on dressing change, the line was noted to be leaking and a crack was discovered.On (b)(6) 2021, the device was removed and replaced.Preliminary examination of the returned product at the manufacturer showed a split in the catheter tubing.No other adverse effects were reported.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation as reported to cook by (b)(6) hospital of new zealand on (b)(6) 2021, a single lumen peripherally inserted central venous catheter set (pics-301-mpis, lot ns13412393) was placed (b)(6) 2021 for delivery of antibiotics and crystalloid intravenous fluids.The device was secured with a securement device.While changing the dressing (b)(6) 2021, the line was noted to be leaking and a crack was discovered.On (b)(6) 2021, the device was removed and replaced.No other adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used device was received.During inspection, a split in the catheter was noticed near the strain relief.The catheter was discovered to be leaking during a leak test.Additionally, a document-based investigation evaluation was performed.Cook reviewed the device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) revealed no additional complaints or nonconformances found for lot ns13412393 or subassembly lot ic13263791.Cook also reviewed product labeling.The product ifu, [t_mpic_rev6] ¿peripherally inserted central venous catheter sets and trays with micropuncture peel-away introducers,¿ provides the following information to the user related to the reported failure mode: warnings ¿-silicone peripherally inserted central venous catheters are not designed for power injection of contrast medium.Catheter rupture may occur.Use of a 10 ml or larger syringe will reduce the risk of catheter rupture.Catheter maintenance catheter entry site must be prepared and maintained in a manner consistent with standard procedure for central venous catheterization.After catheter placement and prior o use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.If catheter is noy to b used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Instruction for use catheter obturator preparation 1- flush catheter with heparinized saline solution or sterile water.Note: the catheter may be trimmed if a shorter length is required.2- attach a syringe with heparinized saline solution or sterile water to the luer lock fitting of the catheter obturator holder.3- inject enough solution to wet the obturator surface entirely.This will activate the aq hydrophilic coating, making the obturator or surface very lubricious.4- remove the obturator from its holder and insert it into the catheter, locking it into position.If the catheter has been trimmed, only advance the obturator to the distal end of the catheter.Note: if the surface of the obturator becomes dry after removal from the holder, wetting with additional heparinized saline or sterile saline will renew the hydrophilic effect.5- the catheter/obturator assembly can now be introduced as described in the following section.Catheter placement (fluoroscopic method) 6- after prepping the access site, introduce the access needle into the vessel.Note: the use of ultrasound is helpful to determine suitability for vessel access and patency.The echotip marking on the needle is used to help visualize the tip of the needle during vessel access.7- using fluoroscopic guidance, introduce the wire guide through the needle and advance it 15-20 cm into the vessel.8- withdraw the needle, leaving wire guide in place.If necessary, enlarge the puncture site with scalpel blade.9- introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.With a twisting motion, advance the assembly into the vessel.10- using fluoroscopic control, determine the correct catheter length by advancing the wire guide to the desired catheter tip location.Once the wire guide tip is in proper position, mark the length by clamping forceps onto the wire guide at the skin site.11- withdraw the wire guide and measure it from the forceps to the distal tip to determine correct catheter length.Trim catheter if necessary.Note: remove obturator prior to trimming the catheter; reinsert for catheter introduction.12- leaving the sheath in place, remove the dilator.Note: to prevent inadvertent air aspiration after removing wire guide and dilator, place thumb or finger over the cuffed proximal end of the sheath.13- introduce the catheter/obturator assembly into the sheath as far as possible.Note: resistance may be felt approximately 7 cm distal to the catheter suture wing when introducing the assembly into the sheath due to an increase in an outer diameter.14- peel the sheath away from the catheter by grasping the two wings of the sheath and pulling outward and upward.Note: final catheter position is accomplished by alternately advancing the catheter into the sheath and then further pulling on the two wings.Once the sheath is removed, a slight advancement of the catheter may be needed for final positioning.15- after catheter is in final position, remove obturator, secure catheter to skin and dress in standard fashion.16- verify the catheter position using radiography or appropriate technology.In order to guarantee extrapericardial location, catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.Every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of the central venous system and to ensure proper delivery of infusates.Catheter placement (non-fluoroscopic method) 1- after prepping the access site, introduce the access needle into the vessel.Note: the use of ultrasound is helpful to determine suitability for vessel access and patency.The echotip marking on the needle is used to help visualize the tip of the needle during vessel access.2- introduce the wire guide through the needle and advance it 15-20 cm into the vessel.3- withdraw the needle, leaving the wire guide in place.If necessary, enlarge the puncture site with scalpel blade.4- introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.With a twisting motion, advance the assembly into the vessel.5- using a tyvek tape measure, clinical judgement, or other institutional protocol, determine the correct catheter length and trim catheter as needed.Note: remove obturator prior to trimming catheter, reinsert for catheter introduction.6- leaving the sheath in place, remove the dilator.Note: to prevent inadvertent air aspiration after removing wire guide and dilator, place thumb or finger over the proximal end of the sheath.7- introduce the catheter/obturator assembly into the sheath as far as possible.Note: resistance may be felt approximately 7 cm distal to the catheter suture wing when introducing assembly into the sheath due to an increase in outer diameter.8- peel the sheath away from the catheter by grasping the two wings of the sheath and pulling outward and upward.Note: final catheter position is accomplished by alternately advancing the catheter into the sheath and then further by pulling on the two wings.Once the sheath is removed, a slight advancement of the catheter may be needed for final positioning.9- after catheter is in final position, remove obturator, secure catheter to skin and dress in standard fashion.10- verify catheter tip position using radiography or appropriate technology.In order to guarantee extrapericardial location, the catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.Every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of the central venous system and to ensure proper delivery of infusates.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for once-time use/ sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the dmr, dhr, ifu, and device failure analysis, there is no indication the complaint device was manufactured out of specification.There is no evidence of manufacturing deficiency.Cook could not identify any nonconforming material in the field or in house.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to component failure.It is possible the catheter was power injected with contrast medium, which could cause catheter rupture; however, this cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12843850
• MDR Text Key: 281013544
• Report Number: 1820334-2021-02524
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002083769
• UDI-Public: (01)00827002083769(17)230906(10)NS13412393
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: N/A
• Device Catalogue Number: PICS-301-MPIS
• Device Lot Number: NS13412393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SECURACATH SECUREMENT DEVICE
• Patient Outcome(s): Required Intervention