MAUDE Adverse Event Report: COOK INC COOK TPN DOUBLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: sr.Clinical risk advisor.Pma/510(k): preamendment.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 that the yellow lumen hub of a cook tpn double lumen catheter repair set was able to pull away slightly from the clear sheath due to a broken glue bond.This issue was found during the investigation for devices returned under mdr# 1820334-2020-00443 and had not been previously reported by the customer.This repair kit had been used on a cook tpn double lumen catheter, and the entire device was ultimately explanted from the patient and sent to cook inc for evaluation.No adverse effects have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation it was reported by alberta children¿s hospital, the sheath of a catheter came loose from a redo double lumen tpn catheter set (part number c-tpns-7.0d-65-redo, lot number 9352833).During investigation of the initial complaint (reported under patient identifier (b)(6) it was discovered the device had previously been repaired using a cook tpn repair kit (part number not reported).This complaint is for the failure of the sheath allowing the hub to twist on the repair section.No information was provided regarding when the seal on the sheath had broken or how the line was used when the event occurred.It was reported that there were no ancillary devices used.The patient was reported to have ¿normal¿ activity level for their age but spends most of their time in the hospital bed.A review of the instructions for use (ifu) and quality control, as well as a visual inspection of the returned device were conducted during the investigation.The complaint device was returned for evaluation.The device examination found that the large (yellow) lumen has pulled from the hub on the repair kit.The upper glue bond on the sheath has failed and the sheath can slide up and down the extension tubing.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the risk file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record and a search for additional complaints could not be carried out due to a lack of lot information from the user facility.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: -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.The following suggested catheter maintenance is also provided ¿.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations 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.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.Appropriate measures have been taken to address this failure mode.A capa was previously opened for this failure mode and 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.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.

Event Description

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

• Brand Name: COOK TPN DOUBLE LUMEN CATHETER REPAIR SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10079769
• MDR Text Key: 198333140
• Report Number: 1820334-2020-00982
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-RHCD-7.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-TPNS-7.0D-65-REDO