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

Catalog Number	305127
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material#: 305127.Batch number#: unknown.Verbatim#: please find attached the needle extender video of the leak that i either mentioned to you or rob a month or 2 ago.I have also attached the needles that they are using.If you could kindly help us trouble shoot as it has been leaking for almost last 1 year and we just bought it last year.
Event or Problem Description
Additional information received describe any patient harm, injury, complication or negative outcome that occurred because of the event - we are losing about 2ml out of 5ml of whatever is being injected due to the leak.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported the needle extender has been leaking.To aid in the investigation, one photo and one video was provided for evaluation by our quality team.The video shows a needle assembly out of the packaging blister, with no plastic shield, and assembled to a syringe extension.While expelling the solution, there is a leak.The photo provided shows the side of a packaging shelf box.No other information could be obtained from the photo or video.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

• 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; s/n; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20844603
• Report Number: 1911916-2024-00870
• Device Sequence Number: 14392600
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2025

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: 305127
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown