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

Catalog Number	305122
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): 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
Materials#: 305122 batch#: 3024981.It was reported by the customer that there is a pinpoint hole in the plastic barrel portion attached to the needle.Verbatim: rcc received a complaint via email.Email(s) attached.Clinic reported: ¿i have had to date 2 needles from this box of needles, where there is a pin point hole in the plastic barrel portion attached to the needle, such that when i go to inject medication through the needle, the liquid medication shoots out the side of the hub.I have two other boxes of needles in addition to my current open box, with the same lot number and expiration date and bar codes.¿ mfg code: 305122.Description: needle bd 25g x 5/8in - 100`s.Lot: 3024981.Expiry: 3/31/2028.Wddc po: pom0105109 | 5-23-2023.(b)(6).I have provided the clinics invoice additionally, as they have 2 boxes.
Event or Problem Description
(b)(4) additional information.I had this issue happen twice, with two separate needles, in the first week of (b)(6) 2023 (12-01-2023 to 12-07-2023).I do not have photos or video of the event happening.In both incidents while i was injecting medication into an animal the medication being injected started shooting out of a pinpoint hole on the side from the plastic hub of the needle.Materials#: 305122 batch#: 3024981.It was reported by the customer that there is a pinpoint hole in the plastic barrel portion attached to the needle.Verbatim: rcc received a complaint via email.Email(s) attached.Clinic reported: ¿i have had to date 2 needles from this box of needles, where there is a pin point hole in the plastic barrel portion attached to the needle, such that when i go to inject medication through the needle, the liquid medication shoots out the side of the hub.I have two other boxes of needles in addition to my current open box, with the same lot number and expiration date and bar codes.¿ mfg code: 305122.Description: needle bd 25g x 5/8in - 100`s.Lot: 3024981.Expiry: 3/31/2028.Wddc po: pom0105109 | 5-23-2023.Clinic name: (b)(6).Address: (b)(6).Contact: dr.(b)(6).I have provided the clinics invoice additionally, as they have 2 boxes.
Additional Manufacturer Narrative
(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 305122 and lot number 3024981.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• 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: 18397593
• Report Number: 1911916-2023-00914
• Device Sequence Number: 2810409
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2024

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: 305122
• Device Lot Number: 3024981
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/07/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown