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

Catalog Number	ULT12.0-38-25-P-6S-CLM-RH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.(b)(4).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 a ultrathane mac-loc locking loop multipurpose drainage catheter was placed for an abscess drain when leaking after was noticed around the hub.The device was removed after about five minutes and a like device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, functional testing, complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the product was in two pieces with biomatter present on the device.No other surface damage was noted.The number of threads visible between the mac-loc hub and connector cap was measured and found to be outside of specification.A leak test was conducted and confirmed the presence of a leak between the catheter tubing and connector cap.Additionally, a document based investigation evaluation was performed.Review of device history record shows no nonconforming events which could contribute to this failure mode.A review of complaints from the same lot was conducted and found no reported complaints associated with this lot number.Based on the document review and the device failure analysis, the actual root cause for the used catheter was found to be manufacturing related.The assembler did not follow the manufacturing instructions to check that the appropriate number of adapter threads were showing for the given french size device.The appropriate personnel have been notified and retrained.Additionally, measures have previously been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.We 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.Investigation ¿ evaluation.A review of the dimensional verification, functional testing, complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the product was in two pieces with biomatter present on the device.No other surface damage was noted.The number of threads visible between the mac-loc hub and connector cap was measured and found to be outside of specification.A leak test was conducted and confirmed the presence of a leak between the catheter tubing and connector cap.Additionally, a document based investigation evaluation was performed.Review of device history record shows no nonconforming events which could contribute to this failure mode.A review of complaints from the same lot was conducted and found no reported complaints associated with this lot number.Based on the document review and the device failure analysis, the actual root cause for the used catheter was found to be manufacturing related.The assembler did not follow the manufacturing instructions to check that the appropriate number of adapter threads were showing for the given french size device.The appropriate personnel have been notified and retrained.Additionally, measures have previously been initiated to address this failure mode per the quality engineering risk assessment, no further action is required.We 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 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: 7502931
• Report Number: 1820334-2018-01447
• Device Sequence Number: 1550315
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)210323(10)8689994
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 06/14/2018

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 Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1