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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is manufacturer quality engineer.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was found ten devices leaked during manufacturer bench testing on unopened, returned ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters.These devices and nine other unopened devices from the same lot were returned against the complaint recorded under medwatch report # 1820334-2019-01959.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: b5.D10 ¿ product received on: 13aug2020.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.Nineteen unused devices were returned against a complaint reported under medwatch report # 1820334-2019-01959.Physical examination of the 19 unused devices showed 10 of the 19 devices having less than two threads showing, no damage and no leakage.Nine of the 19 devices did not pass the leak test.Physical examination of the nine devices that failed the leak test showed no damage to the flare or catheter and the suture glued to the cap.There is also evidence five of the ten devices were not manufactured within specification due to the amount of threads showing.Re-training for this department was completed on (b)(6) 2019 due to implementation of the new gap gauge measurement.Since this lot was manufactured prior to this implementation date, no further re-training for this issue will be completed.The device is shipped with instruction for use (ifu) which notes: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for the complaint lot and related subassembly lots was reviewed and revealed one related nonconformance.This affected a total of five devices that were all scrapped.A database search was completed on the complaint lot and one additional complaint was found.This complaint was reported from the same customer for two used devices that leaked.Based on this information, there is evidence that nonconforming product exists out in the field.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a manufacturing deficiency and quality control deficiency contributed to this incident.Corrective actions including implementation of a gap gauge and retraining were performed.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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
It was originally reported 10 unopened devices failed the table top leak test, however only 9 devices failed the leak test.

• 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: 8945988
• Report Number: 1820334-2019-02159
• Device Sequence Number: 11287452
• Product Code: GBO
• UDI-Device Identifier: 00827002515956
• UDI-Public: (01)00827002515956(17)220611(10)9803175
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Other
• Device Expiration Date: 06/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT6.3-35-25-P-5S-CLDM-HC
• Device Lot Number: 9803175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1