MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number	305950
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insulin syringes were found mixed in with the allergy syringes in the bd allergy syringe tray with bd safetyglide¿ needle.The following information was provided by the initial reporter: "customer orders from alk, received insulin syringes with the allergy syringes (mixed product) stated that some are all allergy (correct) some will have allergy and insulin syringes.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information: see b5 follow up received from customer.Investigation summary: samples were received and an investigation was performed.This is the 4th complaint for the reported lot number.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 and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
Additional information received on 01-may-2023.1.Staff saved 16 unused syringes, used insulin syringes were discarded into sharps containers.2.I notified our (b)(6) representative march 28, 2023.3.The injection nurse notified me she was giving an allergy injection and noticed after she gave the injection it was an insulin syringe.I purchase a standing order of 4 cases of the bd safety glide from (b)(6) each month.It was random which allergy tray of 25 syringes contained the insulin syringes mixed in with the allergy syringes.All syringes came from lot 2221215.No adverse event or injury reported.4.(b)(6).

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ 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: 16858186
• Report Number: 1920898-2023-00275
• Device Sequence Number: 6564401
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: 00382903059508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: Other
• Device Catalogue Number: 305950
• Device Lot Number: 2221315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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