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: 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.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.(b)(4).

Event Description

It was reported that the unspecified bd connecta¿ stopcock was damaged/defective.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of the "bd connecta¿ stopcock is defective or damaged (1)".".

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.The dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported that the unspecified bd connecta¿ stopcock was damaged/defective.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of the "bd connecta¿ stopcock is defective or damaged.".

• 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: 11345989
• MDR Text Key: 266920654
• Report Number: 2243072-2021-00368
• 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: 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