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

Model Number	305540
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd allergy syringe tray with bd precisionglide¿ permanently attached needle there were scale marking issues.The following information was provided by the initial reporter: verbatim the last batch of allergy syringes we purchased seem to have some issues.There are randomly syringes that are missing numbers.Anywhere from 0.4 and up could be missing.See one photo example below.This is becoming an issue as we can not tell ahead of time as to which trays contain ¿defective¿ syringes as they are sealed when we send them home with clients.These are the bd syringes we buy by the case ( 40 trays per case with 25 syringes per tray ) this batch is lot # 2283768 with an expiration of 10/31/2027 i would think bd would want to know about this, and i¿m hoping they would offer some sort of replacement.We are happy to return the remaining in stock syringes so they can check them.We have no way of knowing how many of the remaining trays have syringe issues without first opening them.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17213564
• Report Number: 1920898-2023-00400
• Device Sequence Number: 20598854
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: (01)30382903055402
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: Other
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 2283768
• 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: 06/02/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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