MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Fitting Problem (2183); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a redo single lumen tpn catheter set split when trying to unclog using urokinase with 10ml syringe.The catheter was repaired with a repair kit and a new unclogging attempt took place.The new unclogging attempt resulted in a new leak and the catheter was ultimately replaced, which is covered in another report with the patient identifier: (b)(6).Additional information has been requested regarding event information but is currently unavailable.No adverse effects have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

A device failure analysis conducted on 01jun2020 found that in addition to the split in the catheter, that the hub has pulled out of the silicone sleeve.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation it was reported a redo single lumen tpn catheter set (part number c-tpns-3.0-65-redo, lot number 9571764) split when trying to unclog by urokinase with 10ml syringe.The catheter was repaired with a repair kit and a new unclogging attempt took place.The 2nd attempt to unclog the catheter result in a new leak due to probable overpressure.The catheter was changed and a new set was used.A review of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.The extension tubing portion of the complaint device was returned for evaluation.The device examination found the catheter tubing separated distal to the distal taper of the silicone winged extension.The separation is rough and jagged, not clean cut.Additionally, the silicone cover has come loose from the hub.Functional testing of the returned device segment notes no occlusion.The 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 controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.A review of the design history file (dhf) found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record (dhr) found no nonconformances associated with this device lot.A database search found 2 additional complaints associated with this lot number, both related to this complaint and reported by the same customer.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions 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 catheter 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 evidence from the complaint file, device history record, complaint history, quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for the separation was not established.Possible contributing factors that could not be ruled out include catheter maintenance or excessive pressure as a cause of this event.Appropriate measures have been taken to address this failure mode.A capa was previously opened to address the issue of the hubs of these devices twisting in the silicone sleeve.It was found that the product line meets specifications, but that separation and leakage of the device is an inherent risk device usage.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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.

• Brand Name: REDO SINGLE LUMEN TPN 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
• MDR Report Key: 10020769
• MDR Text Key: 199989960
• Report Number: 1820334-2020-00901
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)220603(10)9571764
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2022
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: 9571764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK TPN CATHETER REPAIR SET