MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CONNECTA STOPCOCK

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.(b)(4).

Event Description

It was reported that 5 unspecified bd connecta¿ stopcocks leaked during use, 3 had loose caps, 1 cap disconnected during use, and 1 stopcock broke.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (5), the bd plug is loose on bd connecta¿ stopcock(s), (3), bd plug inadvertently disconnects from bd connecta¿ stopcock port during use (1), and the stopcock breaks and the cap remains (1).".

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that 5 unspecified bd connecta¿ stopcocks leaked during use, 3 had loose caps, 1 cap disconnected during use, and 1 stopcock broke.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (5), the bd plug is loose on bd connecta¿ stopcock(s), (3), bd plug inadvertently disconnects from bd connecta¿ stopcock port during use (1), and the stopcock breaks and the cap remains (1).".

• Brand Name: UNSPECIFIED BD CONNECTA STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11346927
• MDR Text Key: 233298797
• Report Number: 2243072-2021-00403
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1