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

Catalog Number	305932
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 305932, batch# 4066025.It was reported that the bd syringe 0.5ml 29ga 1/2in bls 400 sg had a syringe needle connectivity issue.The following information was provided by the initial reporter: it was reported by customer that went to un cap the bd safety glide insulin needle to use the syringe and the needle and syringe came out of the cap, but the safety device was stuck and left behind in the cap.Verbatim: rcc received a complaint via email.Email(s) attached.Went to un cap the bd safety glide insulin needle to use the syringe and the needle and syringe came out of the cap, but the safety device was stuck and left behind in the cap.Product# 305932.Lot# 4066025c1.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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: 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: 21043877
• Report Number: 1920898-2024-00159
• Device Sequence Number: 8433591
• Product Code: FMF
• UDI-Device Identifier: 00382903059324
• UDI-Public: (01)00382903059324(11)240517(17)290331(10)4066025
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,User Facility
• 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