MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305194
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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#: 305194.Batch#: 4081103.It was reported by the customer that two 23g needles that have been faulty when trying to inject patients.They seem to be occluded.One wouldn¿t even allow him to push the injection through it at all, and the other one was just extremely difficult to push out.
Event or Problem Description
No additional information received.Material#: 305194; batch#: 4081103.It was reported by the customer that two 23g needles that have been faulty when trying to inject patients.They seem to be occluded.One wouldn¿t even allow him to push the injection through it at all, and the other one was just extremely difficult to push out.Verbatim: rcc received a complaint via email.Email(s) attached.Has had two 23g needles that have been faulty when trying to inject patients.They seem to be occluded.One wouldn¿t even allow him to push the injection through it at all, and the other one was just extremely difficult to push out.Product#: 305194; lot#: 4081103.Additional info: 1.The issue did happen during patient use.This happened whilst dr.(b)(6) was injecting a patient.There were no injuries.2.There was no adverse event or serious injury reported.3.I don¿t have an exact date for the initial occurrence.The second issue occurred on (b)(6).4.There were 2 total occurrences.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the needles seem to be occluded when trying to inject patients.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a packaging shelf box label.No other information could be obtained from the photo.A device history record review was completed for provided material number 305194, lot 4081103.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 photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

• Brand Name: NEEDLE 23X1-1/2 RB TW
• 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: 20280533
• Report Number: 1911916-2024-00691
• Device Sequence Number: 12613840
• Product Code: FMI
• UDI-Device Identifier: 30382903051947
• UDI-Public: (01)30382903051947(11)240321(17)290531(10)4081103
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/02/2024

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: 305194
• Device Lot Number: 4081103
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown