MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 12/02/2020

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.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.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the unspecified bd posiflush¿ syringes had issues with difficult plunger movement and damaged stoppers.The following information was provided by the initial reporter: "it was reported via posiflush pmcf survey that the clinician experienced embolism, dysgeusia, damaged packaging, plunger movement difficulty and damaged syringe stopper within the past 12 months.".

Manufacturer Narrative

H.6.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.A capa is not required at this time.

Event Description

It was reported that the unspecified bd posiflush¿ syringes had issues with difficult plunger movement and damaged stoppers.The following information was provided by the initial reporter: "it was reported via posiflush pmcf survey that the clinician experienced embolism, dysgeusia, damaged packaging, plunger movement difficulty and damaged syringe stopper within the past 12 months.".

• Brand Name: UNSPECIFIED BD POSIFLUSH SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11098721
• MDR Text Key: 224588953
• Report Number: 2243072-2020-02213
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1