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

Model Number	G10435
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the user facility observed a hair within the packaging of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.As a result, the device was left unopened and did not make patient contact.
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
Correction: e1 - customer person, e3 - occupation: regulatory affairs analyst.Additional information: h6 - annex g.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: it was reported that the user facility observed a hair within the packaging of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.As a result, the device was left unopened and did not make patient contact.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control procedures was conducted during the investigation.A visual inspection of the complaint device was also conducted.One sealed, unused device was returned for investigation.A hair-like fiber was noted in the sealed pouch.A document-based investigation evaluation was performed.No related non-conformance's were found, and there have been no other reported complaints for this lot number.Information provided during the investigation suggests that the complaint device was manufactured out of specification.As there were no related nonconformance's and no additional complaints have been received on this lot, there is no evidence of nonconforming devices from the complaint lot in-house or in the field.The product ifu states: ¿sterile if package is unopened or undamaged.Do not use the product it there is doubt as to whether the product is sterile.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the cause for this event is related to a manufacturing/quality deficiency.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or Problem Description
No additional information has been received since the last report was submitted.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11866533
• Report Number: 1820334-2021-01385
• Device Sequence Number: 11037860
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)230605(10)13229122
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2022

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 Expiration Date: 06/05/2023
• Device Model Number: G10435
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 13229122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 01/12/2022
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 12/16/2021; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown