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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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.(b)(4).

Event Description

It was reported that unspecified bd connecta experienced a case of loose/separated/detached stopcock/cap, a case of leakage, a case of kinked tubing, and a case of foreign matter in the fluid pathway.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 foreign matter in packaging (1), leakage (1), tubing kinked (1), and the bd connecta¿ stopcock is defective or damaged (1).

Event Description

It was reported that unspecified bd connecta experienced a case of loose/separated/detached stopcock/cap, a case of leakage, a case of kinked tubing, and a case of foreign matter in the fluid pathway.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 foreign matter in packaging (1), leakage (1), tubing kinked (1), and the bd connecta¿ stopcock is defective or damaged (1).

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.

• Brand Name: UNSPECIFIED BD CONNECTA
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11355362
• MDR Text Key: 266922929
• Report Number: 2243072-2021-00452
• 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: 02/19/2021
• 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