MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328418

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

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.The customer's address is unknown.(b)(6) has been used as a default.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.(b)(4).

Event Description

It was reported that an unspecified number of syringe 1.0ml 31ga 8mm ufii 10bag 500cs had missing label information before use.The following was reported by the initial reporter: "it was reported that the consumer inquired if the syringes are still good to use.Verbatim: consumer called to inquire if her syringes are still good to use.Consumer stated she did not have the product box, only poly bags.Unable to locate a lot # on poly bags.Stated she believes she's had the syringes for about 3 years.Advised consumer these syringes could be expired.".

Event Description

It was reported that an unspecified number of syringe 1.0ml 31ga 8mm ufii 10bag 500cs had missing label information before use.The following was reported by the initial reporter: "it was reported that the consumer inquired if the syringes are still good to use.Verbatim: consumer called to inquire if her syringes are still good to use.Consumer stated she did not have the product box, only poly bags.Unable to locate a lot # on poly bags.Stated she believes she's had the syringes for about 3 years.Advised consumer these syringes could be expired.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to batch being unknown, no dhr can be completed.

• Brand Name: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11378066
• MDR Text Key: 266947096
• Report Number: 2243072-2021-00603
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 328418
• Device Catalogue Number: 328418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1