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

Catalog Number	305125
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 9125250: initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a1409 - obstruction of flow.Patient problem code: f24 ¿ insufficient information.
Event or Problem Description
Material#: 305125.Batch: 3083975.It was reported by customer that they are able to draw it out of the vial.However, they are unable to push the vaccine into the muscle.They attempted again a second time, and the same thing happened.Incident date: (b)(6) 2023.
Additional Manufacturer Narrative
(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 305125 and lot number 3083975.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.
Event or Problem Description
No additional information received material#: 305125 batch: 3083975 it was reported by customer that they are able to draw it out of the vial.However, they are unable to push the vaccine into the muscle.They attempted again a second time, and the same thing happened.Incident date: 24oct2023 verbatim: rcc received a complaint via phone.Pir attached.(b)(6).Ref 305125 needle 25x1 rb lot 3083975 they are able to draw it out of the vial.However, they are unable to push the vaccine into the muscle.They attempted again a second time, and the same thing happened.Incident date: 24oct2023 they still have the needles to send in for investigation, if needed.

• Brand Name: NEEDLE 25X1 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18082994
• Report Number: 1911916-2023-00827
• Device Sequence Number: 6591565
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: (01)30382903051251
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 305125
• Device Lot Number: 3083975
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown