MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG VALVE TB 100CM; STOPCOCK

Catalog Number 394971

Device Problem Leak/Splash (1354)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the connecta wht 360deg valve tb 100cm experienced leakage during use.The following information was provided by the initial reporter: the 100 cm iv tubing (extension) is used with iv fluid giving set, then connects to the patient¿s venous cannula.Tubing has a two way tap and an injection port below the tap.Injection port has a top.Injection port was found to be leaking iv fluids regardless of the valve on the injection port.

Manufacturer Narrative

Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.A sample was submitted for evaluation and testing.No abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.

Event Description

It was reported that the connecta wht 360deg valve tb 100cm experienced leakage during use.The following information was provided by the initial reporter: the 100 cm iv tubing (extension) is used with iv fluid giving set, then connects to the patient¿s venous cannula.Tubing has a two way tap and an injection port below the tap.Injection port has a top.Injection port was found to be leaking iv fluids regardless of the valve on the injection port.

• Brand Name: CONNECTA WHT 360DEG VALVE TB 100CM
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9250629
• MDR Text Key: 192047649
• Report Number: 9610847-2019-00647
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394971
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other