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

Catalog Number 394605

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

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.(b)(4).

Event Description

It was reported that 5 bd connecta¿ stopcocks leaked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "after the customer opened the package and used the syringe, he found that the liquid would leak from the other end of the connecta, demanding compensation and giving an explanation.".

Manufacturer Narrative

Investigation summary: a complaint of a leaking product was received from the customer.Sample were returned to aid in the investigation of this defect.Through testing the customer's complaint was not able to be reproduced.A device history record review was completed by our quality engineer team for provided lot number 0059894.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.A root cause could not be determined due to the defect not being able to be replicated.

Event Description

It was reported that 5 bd connecta¿ stopcocks leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "after the customer opened the package and used the syringe, he found that the liquid would leak from the other end of the connecta, demanding compensation and giving an explanation".

• 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: 11355423
• MDR Text Key: 233261059
• Report Number: 9610847-2021-00076
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 394605
• Device Lot Number: 0059894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1