MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: not available as this device is not sold in the us, but it is considered to be similar to a device that is.Occupation: buyer.Pma/510(k): not available as this device is not sold in the us, but it is considered to be similar to a device that is.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a redo single lumen tpn catheter set broke while underneath the dressing.The device was placed in the right arm of the patient for long-term infusion of antibiotics and was secured with a cvc dressing.The device was in place for 12 days prior to failure.The patient was in bed at night resting when the device broke, however the patient was otherwise described as active.No procedure was being attempted at the time of the breakage.It was noted that the catheter completely separated into two pieces at the "thick to thin junction below the hub of the line".The patient required a minor additional procedure to repair the catheter.No adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported by bc children`s & women health that a catheter from a redo single lumen tpn catheter set (part number c-tpns-3.0-65-redo, lot number 9530701) broke under the patients dressing.The catheter broke at the "thick to thin junction below hub of line".The catheter was completely separated in 2 pieces.The catheter was repaired after it separated.There was no adverse effects to the patient reported as a result of this event.The indication for placement of this device was long-term infusion of antibiotics.No procedures were being performed at the time of breakage.The device was in place for 12 days prior to failure.The catheter was placed in the right arm.The device was secured to the patient with a cvc dressing.The patient was in bed resting at the time the device broke.The patient was otherwise active.As part of the investigation for the break in the catheter it was identified the glue joint between the winged hub and adjacent clear silicone tubing had separated.This complaint documents the investigation of both failures.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One redo single lumen tpn catheter set was returned for evaluation.The partial returned device is the proximal section of the catheter.Upon physical examination, it was noted that the silicone cover has come loose from the hub.The catheter tubing was separated at the distal taper of the silicone winged extension.This separation was not clean or even.A section of the material looks stretched and material strain is present.Functional testing of the returned device segment notes no occlusion.Catheter patency was verified with a guide wire and using a syringe to flush with water.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that current quality controls are in place to assure functionality ad device integrity prior to shipping.A review of the design history file (dhf) concluded that the benefits of the device outweigh the benefits.A review of the device history records (dhr) for lot 9530701 and catheter lot ni9530700 were found to have no nonconformances recorded that could have contributed to the reported failure mode.There was one additional complaint reported for this lot number for the same device referenced in this investigation.The information provided upon review of complaint file, device history record, complaint history, quality control documents and device failure analysis indicate the complaint device and devices for the same lot, similar devices in house and in the field meet cook`s specification.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warning: -if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately precautions: -silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance: after catheter placement and prior to 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 the physician.If catheter is not to be used immediately, its lumen should be drip maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentration of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency, catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter.The appropriate personnel have been notified.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause of the failure could not be established.A previous project was performed to determine the cause of this issue.It was found that the product line meets specifications, but that separation and leakage of the device is an inherent risk device usage.The properties of silicone may result in lower material strength when compared to catheters constructed of other stronger material (e.G.Polyurethane).This lower strength leads to the potential risk of more catheter separations/leakages due to a variety of causes.The benefits of the catheter constructed of silicone include softer feel for greater patient comfort, longer-term biocompatibility, ability to repair outside the body, and is less thrombogenic than polyethylene or pvc.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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.
Event or Problem Description
A device failure analysis was conducted on 01jun2020 for the returned device and found that in addition to the break in the line, the silicone sleeve has come loose from the winged hub, which was not reported by the customer.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10048335
• Report Number: 1820334-2020-00939
• Device Sequence Number: 19603793
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)220426(10)9530701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: 9530701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1