MAUDE Adverse Event Report: BECTON DICKINSON 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
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material# 305904, batch# unknown.It was reported by customer that this issue occurred with the needle from 3ml 25gx 5/8¿ ref (b)(4) 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.(see attached photos).The bd safety glide thin wall 25 gx1¿ mckesson # 408164 bd #3 05916 are currently on backorder, so they were using the needle from the package of the 3ml 25gx 5/8¿ ref (b)(4).They currently have the needle that broke secured in a sharps container.Additional information: no, there was no diagnostics performed because of the needle stick ( it was a flu shot that was given to the patient at the time ).We just sent the entire needle /shot back to manufacture for their inspection.We had both the patient and ma who gave the shot have blood work completed (followed our needle stick policy protocol ).Everything was found to be with in normal circumstances.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needle broke off at the non-administration end.To aid in the investigation, one sample with no packaging blister and three photos were provided for evaluation by our quality team.A visual inspection was performed.The safety mechanism has been activated and the needle is out of the hub.The adhesive applies to the needle-needle hub joint was insufficient.The three photos provided show the sample received and a packaged product.No other defects or imperfections were observed.This defect could occur if there was a misfeeding of the cannulator.A device history record review was completed for provided material number 305904, lot 4059264.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20546079
• Report Number: 1911916-2024-00769
• Device Sequence Number: 8886072
• 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
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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