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

Catalog Number	ULT14.0-38-25-P-6S-CLM-RH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
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 during chest tube placement the hub on a ultrathane mac-loc locking loop multipurpose drainage catheter broke off.For replacement, the 14fr drain was removed over a wire and a 16fr drain was placed over the wire.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 complaint history, device history record, documentation and a visual inspection/ dimensional verification of the returned device were conducted during the investigation.The device was returned and visual inspection is able to confirm the complaint of hub separation.The returned device is in three pieces: mac-loc hub, flared tubing, and shaft.Examination leads us to believe the catheter was cut which is why the flare has been separated from the shaft.Inspection of the flare makes is seem larger than specified in drawing specification.However, we cannot confirm this to be conforming due to possible damage or deforming when being removed/pulled from the mac-loc and cap assembly.All other measurements are within specifications and therefore we cannot confirm this device to be non-conforming.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the finished product lot device history record showed two non-conformances (lot 8481992); both related.The first non-conformance was for an inadequate flare of 1 device which was scrapped.The second non-conformance was for insecure fitting of 1 device which was scrapped.It should be noted there were no other reported complaints 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.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected data: cook inc.Sent follow up #2 as mdr 1820334-2018-01208.
Event or Problem Description
No new event description information to report at this time.

• 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: 7503675
• Report Number: 1820334-2018-01407
• Device Sequence Number: 13897121
• Product Code: GBO
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)210102(10)8481992
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/14/2018

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: ULT14.0-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 06/13/2018; 08/14/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/25/2018; 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR