MAUDE Adverse Event Report: COOK INC MULTIPURPOSE PLASTIC TUBING ADAPTER; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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
The international customer reported that the was a leakage of urine which occurred at the junction between the connecting piece and the body of the multipurpose plastic tubing adapter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence, and no additional procedures were required.
Additional Manufacturer Narrative
Corrected information: report source: foreign, health professional, user facility, distributor.Investigation summary: a review of the complaint history, device history record, documentation, drawing, quality control, manufacturing instructions, functional testing and visual inspection of the returned device were conducted during the investigation.One adapter was returned in used condition with no biomatter present.There was no visible damage to the device.A leak test was performed by injecting water without plugging the device and no leaking was observed.When the distal end of the adapter was plugged, leaking was observed between the luer lock adapter and foley adapter.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.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.However, appropriate measures have been initiated to address this failure mode.The appropriate personnel will be notified and we will continue to monitor for similar complaints.

• Brand Name: MULTIPURPOSE PLASTIC TUBING ADAPTER
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6824943
• Report Number: 1820334-2017-02734
• Device Sequence Number: 10978303
• Product Code: KGZ
• UDI-Device Identifier: 00827002044722
• UDI-Public: (01)00827002044722(17)210906(10)7251793
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: PFLLA-VTA-L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1