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.Device expiration date: unknown.Initial reported phone #: an additional phone # was provided as +(b)(6).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 2 cases of loose/separated/detached stopcocks/caps, 5 cases of tubing separation from the adapter/luer connector, device damage/deformation while still considered operable.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 stopcock inadvertently disconnects from mating component (2), tubing disconnects from stopcock (5), and "cap that gives under pressure" (10).

Manufacturer Narrative

H6: 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.H3 other text : see h10.

Event Description

It was reported that unspecified bd connecta experienced 2 cases of loose/separated/detached stopcocks/caps, 5 cases of tubing separation from the adapter/luer connector, device damage/deformation while still considered operable.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 stopcock inadvertently disconnects from mating component (2), tubing disconnects from stopcock (5), and "cap that gives under pressure" (10).

• Brand Name: UNSPECIFIED BD CONNECTA
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11346617
• MDR Text Key: 233300818
• Report Number: 2243072-2021-00398
• 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

• 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
• 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