MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305122 batch#: 3055929 it was reported by the customer that customer experiencing issue with the needle now letting liquid through requiring you to push the syringe hard then it pops off.It also has liquid leaking through.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no item: 305122 quantity affected: 2 bx serial/lot number: (b)(6) po : 4516894105 are any samples available for return? yes reported issue: customer experiencing issue with the needle now letting liquid through requiring you to push the syringe hard then it pops off.It also has liquid leaking through.Comments on 24/05/2024 may 15th 2024.
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
No additional information received.Material#: 305122.Batch#: 3055929.It was reported by the customer that customer experiencing issue with the needle now letting liquid through requiring you to push the syringe hard then it pops off.It also has liquid leaking through.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no item: 305122.Quantity affected: 2 bx.Serial/lot number: (b)(6) po : (b)(4).Are any samples available for return? yes.Reported issue: customer experiencing issue with the needle now letting liquid through requiring you to push the syringe hard then it pops off.It also has liquid leaking through.Comments on 24/05/2024.May 15th 2024.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported there was an issue with the needle letting liquid through.To aid in the investigation, two samples were received for evaluation by our quality team.One sample came in an opened packaging blister and one sample came in a sealed packaging blister.A visual inspection was performed.The sealed packaging blister has only the plastic shield in it; the needle assembly is missing.The other sample has no defects or imperfections.This sample was assembled to a syringe with saline solution; the solution expelled with a normal flow.A device history record review was completed for provided material number 305122, lot 3055929.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 could not be confirmed.

• Brand Name: NEEDLE 25X5/8 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: 19410501
• Report Number: 1911916-2024-00383
• Device Sequence Number: 19636827
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/09/2024

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: 305122
• Device Lot Number: 3055929
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown