MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALLERGY 1/2ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	305535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305535.Batch # 2136739.It was reported that the bd syringe allergy 1/2ml w/ndl 27x1/2 rb needle was broken.The following information was provided by the initial reporter: verbatim: rcc received a complaint via phone.Pir attached.305535 lot 2136739.Needle broke off after the hcw drew up the extract, no patient impact.Samples available for investigation.Replacement.
Additional Manufacturer Narrative
Investigation summary: 33 unused needle trays were received and tested by our quality team with the customer's complaint of a broken needle.All 825 needles were tested by bending and pulling on needle and no issues were found.Without further information like the affected sample the complaint cannot be verified and the root cause remains unknown.
Event or Problem Description
Samples received.

• Brand Name: BD SYRINGE ALLERGY 1/2ML W/NDL 27X1/2 RB
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20767766
• Report Number: 1920898-2024-00154
• Device Sequence Number: 13077418
• Product Code: FMF
• UDI-Device Identifier: 00382903055357
• UDI-Public: (01)00382903055357(11)220516(17)270531(10)2136739
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: Health Professional
• Device Catalogue Number: 305535
• Device Lot Number: 2136739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown