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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 or Problem Description
It was reported an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was inspected at a distributor.A hair-like fiber was noted inside the primary packaging of the product.There was no patient involvement.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.Agility logistics in brazil informed cook that on (b)(6) 2021 they noted foreign matter in the sealed packaging of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from lot 13504258.The failure was noted at the distributor, and no patient care was impacted.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as a visual inspection of photos provided by the distributor, were conducted during the investigation.The customer did not return the complaint device.They did provide several photos of the sealed package.All seals appear to be intact, and there is a hair-like fiber visible inside the outer pouch.Cook confirmed the device was manufactured out of specification based on the provided photos.Additionally, a document based investigation evaluation was performed.The packaging is 100% inspected for this failure prior to distribution.The design history file contains controls relevant to this failure.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 supplied sterilized by ethylene oxide gas in peel-open packages.Do not use the product if there is doubt as to whether the product is sterile." 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 did not have nonconformances.There are no additional complaints on this lot.There is no evidence of additional nonconforming material or complaints from the field.Based on the information provided, the examination of photos provided by the customer, the cause of this event is quality control deficiency.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: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11272930
• Report Number: 1820334-2021-00240
• Device Sequence Number: 3494116
• Product Code: GBO
• UDI-Device Identifier: 00827002104365
• UDI-Public: (01)00827002104365(17)231021(10)13504258
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: No Information
• Device Expiration Date: 10/21/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 13504258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1