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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); 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.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd connecta experienced 5 cases of being loose/detached/separated stopcocks/caps and 20 cases of flow issues.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 no flow or reduced flow of fluids (20), and the bd connecta¿ stopcock is defective or damaged (5).Additional information: "new placement of iv access.".

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.H3 other text : see h.10.

Event Description

It was reported that unspecified bd connecta experienced 5 cases of being loose/detached/separated stopcocks/caps and 20 cases of flow issues.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 no flow or reduced flow of fluids (20), and the bd connecta¿ stopcock is defective or damaged (5).Additional information: "new placement of iv access.".

• Brand Name: UNSPECIFIED BD CONNECTA
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11359030
• MDR Text Key: 266928945
• Report Number: 2243072-2021-00503
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1