MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ syringe was leaking.This was discovered before use.The following information was provided by the initial reporter: it was found that the syringe was leaking when the liquid was pumped.

Manufacturer Narrative

H.6.Investigation summary bd has not been provided with photos or samples to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.No dhr review can be carried out as lot number is unknown.Bd concludes that the cause of the problem could be produced because of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Considering our in-coming and in-process inspection, no corrective actions are required at this time.H3 other text : see section h.10.

Event Description

It was reported that unspecified bd¿ syringe was leaking.This was discovered before use.The following information was provided by the initial reporter: it was found that the syringe was leaking when the liquid was pumped.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9536975
• MDR Text Key: 178026875
• Report Number: 2243072-2019-02929
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other