MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CONNECTA; STOPCOCK

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354); Packaging Problem (3007)

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.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 unspecified bd connecta experienced 25 cases of stopcocks/caps that were loose/separated/detached, 5 cases of kinked tubing, 2 cases of device damage/deformation, and 8 cases of damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of the stopcock inadvertently disconnects from mating component (15), tubing disconnects from stopcock (10), tubing kinked (5), the bd connecta¿ stopcock is defective or damaged (2), and package seal open before use (8).

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history record review could not be performed because a model or lot number was not provided by the customer.

Event Description

It was reported that unspecified bd connecta experienced 25 cases of stopcocks/caps that were loose/separated/detached, 5 cases of kinked tubing, 2 cases of device damage/deformation, and 8 cases of damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of the stopcock inadvertently disconnects from mating component (15), tubing disconnects from stopcock (10), tubing kinked (5), the bd connecta¿ stopcock is defective or damaged (2), and package seal open before use (8).

• Brand Name: UNSPECIFIED BD CONNECTA
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11355434
• MDR Text Key: 233297563
• Report Number: 2243072-2021-00451
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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