MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; SYRINGE, ANTISTICK

Catalog Number	305904
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl sftygld 25x5/8 rb needle was broken.The following information was provided by the initial reporter: verbatim: per customer " the bd safety glide thin wall 25 gx1¿ mckesson #408164, bd #305916 are currently on backorder so they were using the needle from the package of the 3ml 25gx 5/8¿ ref 305904.They currently have the needle that broke secured in a sharps container." per customer "this issue occurred with the needle from 3ml 25gx 5/8¿ ref 305904 bd safety glide which was ordered from mckesson.They attached the needle from this set to a prefilled flu vaccine syringe.Exp 2/28/2029 and lot 4059264.During a flu vaccination to a patient the medical assistant went to flip the safety into place after administering the vaccine and the needle broke off at the non-administration end shifted back and poked through her glove, results in a needlestick injury to the employee.The bd safety glide thin wall 25 gx1¿ mckesson #408164 bd #305916 are currently on backorder so they were using the needle from the package of the 3ml 25gx 5/8¿ ref 305904.They currently have the needle that broke secured in a sharps container." no further details provided.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.This complaint was found to be a duplicate after the mdr was submitted, please refer to mdr (b)(4).

• Brand Name: BD SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20614326
• Report Number: 1213809-2024-00791
• Device Sequence Number: 7354161
• Product Code: MEG
• UDI-Device Identifier: 30382903059042
• UDI-Public: (01)30382903059042(11)240312(17)290228(10)4059264
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 11/07/2024

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: 305904
• Device Lot Number: 4059264
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown