MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that the hub of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter had a leak.Event was noted while the user was aspirating bile using a syringe.The device was explanted and returned for evaluation.It is not known if the patient required a replacement device.The customer reports there was no patient impact.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional test of the returned device were conducted during the investigation.The complaint device was returned in an open, used condition.The visual inspection of the interior of the device confirmed that a silicone insert was positioned incorrectly, which created a gap that allowed fluid to leak through.Additionally, the mac-loc assembly was leak tested and a leak was confirmed between the cap and assembly.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6409739
• Report Number: 1820334-2017-00397
• Device Sequence Number: 16309380
• Product Code: FGE
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)191129(10)7475737
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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 Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1