MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 394945

Device Problem Leak/Splash (1354)

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use of the bd connecta¿ stopcock there is a plug in the filter.Leakage took place at union between the key and the extension.This occurred on 10 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: connecta 7cms is filtered by filter plug.The leakage occurred in the union between the key and the extension.There was no damage to the patient/health professional.There was no exposure of blood or chemotherapy to the skin or mucous.

Event Description

It was reported that during use of the bd connecta¿ stopcock there is a plug in the filter.Leakage took place at union between the key and the extension.This occurred on 10 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from spanish to english: connecta 7cms is filtered by filter plug.The leakage occurred in the union between the key and the extension.There was no damage to the patient/health professional.There was no exposure of blood or chemotherapy to the skin or mucous.

Manufacturer Narrative

H.6.Investigation: one picture sample was received for evaluation by our quality engineer team.Through examination of the provided picture, it was determined that leakage occurred at the injection port.A device history record review was completed for provided lot number 8180509.The review did not reveal any signs of non-conformance during the production process.It is probable that the leakage resulted from improper tubing assembly.The engineering team assessed the assembly process and found a worn station that could have produced this incident.Since the production of lot number 8180509, a corrective and preventive action plan, capa#629955, was initiated and completed for the issue of injection valve leakage.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 9318493
• MDR Text Key: 191726477
• Report Number: 9610847-2019-00681
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8180509
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other