MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material # 305127, batch # 3299707.It was reported by customer that precision glide needle broke off in pt at the hub, x-ray and scheduled surgery for removal.
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.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needle broke off from the hub.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed.First, with 10x magnification, and then with 30x magnification.The sample is the needle hub with no plastic shield.The bottom part of the needle is in the needle hub, and there is about 1/64" of the needle visible from the epoxy.The needle is bent with an angle of about thirty degrees.This defect could occur if the needle became bent and then broke during use.A device history record review was completed for provided material number (b)(4), lot 3299707.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.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: NEEDLE 25X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 20522150
• Report Number: 1911916-2024-00756
• Device Sequence Number: 7920330
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275(11)231026(17)281231(10)3299707
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305127
• Device Lot Number: 3299707
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown