MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	324909
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 6 boxes of bd veo¿ insulin syringes with bd ultra-fine¿ needle were used past the expiration date.The following information was provided by the initial reporter: "consumer called to check expiration date on syringes.Based on product information provided, syringes have expired.Consumer is upset pharmacy sold her expired syringes.Consumer stated she used 6 packs of 10 so far and she has 4 packs left".
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-feb-2023.H6: investigation summary customer returned 4 empty open polybags, one empty open packing box associated with lot# 6179806 and 37 loose syringes.It was reported by the consumer that syringes were expired and were used.Investigation will be assigned to manufacturing unit holdrege for further evaluation.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue, however, this product was manufactured in september 2016 and shipped out of the manufacturing plant on 9th september 2016 with an expiry date of august 2021 which gives enough time to the retailers or distribution centers to sell it to the customers.Since there is no link back to discrepancy in manufacturing and nothing wrong with labelling, the product was good to be used until expiry.Root cause ¿ no quality notifications or dispatches pertained to the complaint; therefore, no root cause can be determined.H3 other text : see h10.
Event or Problem Description
It was reported that 6 boxes of bd veo¿ insulin syringes with bd ultra-fine¿ needle were used past the expiration date.The following information was provided by the initial reporter: "consumer called to check expiration date on syringes.Based on product information provided, syringes have expired.Consumer is upset pharmacy sold her expired syringes.Consumer stated she used 6 packs of 10 so far and she has 4 packs left".

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16440722
• Report Number: 1920898-2023-00068
• Device Sequence Number: 5860004
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 324909
• Device Catalogue Number: 324909
• Device Lot Number: 6179806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown