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	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is manufacturer quality engineer.Occupation: quality engineer.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
During manufacturer bench testing of returned devices, six unused ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters were found to leak.These catheters and nine other unused catheters from the same lot were originally returned against medwatch report #1820334-2019-01891 as unused devices for investigation.These devices did not make patient contact.They were returned unused in the original sealed packaging.
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.D10 ¿ product received on: (b)(6) 2020.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.Fifteen unused devices were returned against medwatch report #1820334-2019-01891 for investigation.Examination of the devices showed all devices sealed within original packaging and no damage on any of the devices.Each device was leak tested and six devices were confirmed to leak where the connector cap meets the catheter tubing.The distance between the hub and the cap was measured for the six devices that leaked and all six were confirmed to be out of specification.The suture was either partially or completely wound in the threads in four of the leaking devices.The flare appeared slightly shallow and contained a lip in all six devices.Re-training for this department was completed on 31jul2019 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.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 ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed no reported nonconformances.A review of complaint software that seven other complaints are associated with this complaint lot.All of these complaints were either reported from the field for leakage, or were opened due to leakage of returned unused devices from the field.Based on this information, there is evidence that nonconforming product exists out in the field.Based on the information provided, inspection of the returned product and the results of the investigation, cook has concluded that a manufacturing 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.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: 8944026
• Report Number: 1820334-2019-02155
• Device Sequence Number: 10844868
• Product Code: GBO
• UDI-Device Identifier: 00827002515949
• UDI-Public: (01)00827002515949(17)220610(10)9799196
• 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): 01/16/2020

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: 06/10/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT6.3-35-15-P-5S-CLDM-HC
• Device Lot Number: 9799196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1