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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

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 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.

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
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6824943
• MDR Text Key: 83893532
• Report Number: 1820334-2017-02734
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002044722
• UDI-Public: (01)00827002044722(17)210906(10)7251793
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PFLLA-VTA-L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1