MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).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 an ultrathane mac-loc locking loop multipurpose drainage catheter was inspected prior to use.A hair was noticed in the primary packaging of the product.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation.Brigham & women's hospital (united states) informed cook that they noticed a hair inside the packaging of an ultrathane mac-loc locking loop multipurpose drainage catheter.The device was not used.A review of the complaint history, device history record, instructions for use (ifu), quality control, were conducted during the investigation.The customer did not return the device and did not provide photos of the failure.Therefore, no visual inspection was performed.Additionally, a document-based investigation evaluation was performed.There are adequate inspection activities in place to detect foreign matter prior to distribution.The device history record (dhr) was reviewed.The lot revealed no nonconformances.A complaint database search was completed.No additional complaints were found for the lot.Based on this information, there is no evidence of nonconforming material in house or in the field.The instructions for use provided with this lot [t_multi_rev5] state: "sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." because the device was not returned and no photos were provided, cook cannot confirm the device was nonconforming.Based on the information provided, no examination of returned product, and the results of the investigation, it is possible that a manufacturing or quality control deficiency caused the failure.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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9716992
• MDR Text Key: 201056615
• Report Number: 1820334-2020-00368
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)221106(10)10134123
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

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
• Device Operator: No Information
• Device Expiration Date: 11/06/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-45-P-6S-CLM-RH
• Device Lot Number: 10134123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1