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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: supply coordinator.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 mac-loc locking loop multipurpose drainage catheter was removed from the package and the hub was detached.No string was noticed on the device.The device never made patient contact and no patient care was impacted.
Event or Problem Description
No new information added to the event description at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, manufacturing instructions, quality control, documentation, specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The visual inspection of the returned device confirmed the catheter was completely separated form the mac-loc hub.No surface damaged was noted.The catheter outer diameter, connector cap inner diameter, and number of threads were measured and confirmed to be within specifications.Removing the cap revealed some suture wound around the hub threads.Rough edges, or flash, was noted along the inner lumen of the mac-loc distal end.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.A review of the device history record showed no related nonconformances.A review of the subassembly lots showed no related nonconformances.It should be noted there are no other complaints reported for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.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.
Event or Problem Description
It was reported in additional information received on 05dec2018 that the hub detached from the catheter as the tech was taking the device out of the package.The suture string detached at that time as well.It appeared that nothing was wrong when the device was inside of the package.It was later clarified on (b)(6) 2018 that the issue was with the hub coming off of the catheter, not the suture string being detached or broken.When the hub came off of the catheter, the suture string was no longer attached to the catheter either.
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

• Brand Name: ULTRATHANE 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: 8070357
• Report Number: 1820334-2018-03394
• Device Sequence Number: 19380825
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)210904(10)9136952
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2019

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: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Device Lot Number: 9136952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 01/11/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/28/2018; 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1