MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 29GA 1/2IN BLS 400 SG; SYRINGE, ANTISTICK

Catalog Number	305932
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305932 , batch # 4066025.It was reported that the bd syringe 0.5ml 29ga 1/2in bls 400 sg safety mechanism was loose / spins freely.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Nurse went to draw up insulin with syringe and the entire (white) safety piece came off the syringe.Lot #: 4066025c1.
Additional Manufacturer Narrative
Imdrf codes must be updated.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD SYRINGE 0.5ML 29GA 1/2IN BLS 400 SG
• Common Device Name: SYRINGE, ANTISTICK
• 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: 21044531
• Report Number: 1920898-2024-00160
• Device Sequence Number: 3277735
• Product Code: MEG
• UDI-Device Identifier: 00382903059324
• UDI-Public: (01)00382903059324(11)240517(17)290331(10)4066025
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 305932
• Device Lot Number: 4066025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown