MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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#: 305196, batch number#: 4093946, 3236138.To date, there have been no known incidents involving patient harm or injection of particulate during patient care.All events were identified prior to injection and discarded immediately.Verbatim: it was reported by customer that an increase amount of needle coring of foreign matter.2 separate lot numbers identified for more than 2 occurrences.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there is an increased amount of needle coring.To aid in the investigation, twenty samples in sealed packaging blisters and four photos were received for evaluation by our quality team.A visual inspection was performed to the samples returned with 30x magnification.There was no damage, defective grind or hooks observed.The bevels and etch were good.The four photos provided show packaging blister top webs and syringes with a dark colored speck in the solution.No other information could be obtained from the photos.A device history record review was completed for provided material number 305196, lots 4093946 and 3236138.The review did not reveal any detected quality issues during the production of these lots 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 these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 18X1-1/2 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: 20902377
• Report Number: 1911916-2024-00884
• Device Sequence Number: 8906289
• Product Code: FMI
• UDI-Device Identifier: 30382903051961
• UDI-Public: (01)30382903051961(11)240402(17)290531(10)4093946
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/16/2025

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: 305196
• Device Lot Number: 4093946
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown