MAUDE Adverse Event Report: COOK INC LOCK PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number C-PCS-830-LOCK

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.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 to cook by a distributor that unknown foreign matter was found within the unopened packaging of a lock pericardiocentesis catheter set.No patient contact was made.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that foreign matter was founding in the packaging of two lock pericardiocentesis catheter sets from lot 13656498.Cook became aware of this event upon being notified by medik inc.This was noted by a distributor so the devices did not make patient contact.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned products, were conducted during the investigation.The complaint devices were returned sealed in their original packaging.Small white and dark fibers were visible within the pouches.Additionally, a document based investigation evaluation was performed.Review of the device master record has shown that sufficient controls are in place to detect this failure mode prior to release.The product¿s design history file (dhf) was reviewed and the risks associated with this device were acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "how supplied: sterile if package is unopened or undamaged.Upon removal from package inspect the product to ensure no damage has occurred." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot showed no nonconformances.A database search revealed no other complaints under this lot number at the time of this investigation.All devices from this lot were shipped to the same distributor.Since no other products from this lot were reported by the distributor to experience this failure, there is no evidence that additional nonconforming product exists in house or in the field.Based on the information provided, confirmation of fibers within the sealed packaging, and the results of the investigation, it was concluded that a manufacturing deficiency contributed to the failure mode.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

This occurred with two devices from the same lot.

• Brand Name: LOCK PERICARDIOCENTESIS CATHETER SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11357686
• MDR Text Key: 266304593
• Report Number: 1820334-2021-00366
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10827002024332
• UDI-Public: (01)10827002024332(17)231229(10)13656498
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/29/2023
• Device Catalogue Number: C-PCS-830-LOCK
• Device Lot Number: 13656498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1