MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd® allergy syringe with permanently attached needle the plunger rod was damaged.There was no report of patient impact.The following information was provided by the initial reporter: are you able to provide the date of event in format dd-mmm-yyyy? (b)(6) 2023.How many occurrences of syringe(s) affected? at least 3.Was issue being described noted before, or during used? during.Any adverse events or serious injury reported to patient or healthcare professional? no - only wasted extract.Was there any patient involvement? yes.What was the patient outcome? medication could not be administered, needed a second injection.Was there any delay of, or change in, the course of treatment due to this event? temporary delay.What procedure was being performed? subcutaneous allergy injection.What medication was used in the procedure? allergy serum.Is sample available for return to bd for investigation? no.If sample is available to be returned, does the sample contaminated with blood/body fluid/hiv or chemo? yes- blood.Was there any medical intervention due to this event? no.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 17321719
• Report Number: 1920898-2023-00443
• Device Sequence Number: 17868328
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: (01)30382903055402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2023

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: 2221352
• 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: 06/21/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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