MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328468

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that a syringe 0.5ml 31ga 8mm ufii 10bag 500cs was damaged before use.The following was reported by the initial reporter: "it was reported that the syringe had a defective plunger, the thumb press is missing.Verbatim: from phone call on (b)(6) 2021, 17:07:43: consumer stated, removed needle shield prior to injection and found needle missing.Stated, found damaged plungers; thumb press was missing.Stated, his wife discarded samples when he was in hospital, just got out today, (unrelated to complaint).Samples: no.(b)(4).Pir attached to file.Information from email copied.Email received on 2021-03-09, 13:35:09.Customer called in to report that about 90% of his box of insulin syringes had a defective plunger.The part where his thumb would be placed was missing.He stated that he has the defective syringes in his sharps container.".

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11607228
• MDR Text Key: 268796235
• Report Number: 2243072-2021-00925
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

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: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1