MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305167
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 305167 batch#: 2228394 it was reported by the customer that defect in the needle coating, a cut in the needle coating.Verbatim: defect in the needle coating, a cut in the needle coating.
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.Device problem code: a0415 - scratched material patient problem code: f27 ¿ no patient involvement.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported there was a defect in the needle coating.To aid in the investigation, one hundred forty-five samples were received for evaluation by our quality team.One hundred forty-four samples were in sealed packaging blisters and one sample had no packaging blister.In addition to the sample with no packaging blister, eighty samples were randomly selected for investigation, for a total of eighty-one samples.A visual inspection was performed with 30x magnification, and no defects or imperfections were observed.A device history record review was completed for provided material number 305167, lot 2228394.The review did not reveal any detected quality issues during the production of this lot that could have contributed 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 and a probable root cause could not be determined.
Event or Problem Description
Pr (b)(4) additional information received.I have physical samples i can send for the investigation.I can send a box of needles, and one needle that was not used which we examined and noticed a defect.It was noticed that the silicone coating on the exterior of the needles looks to have variable defects.These defects can lead to potential leeching of metal from the needles in our production process when used with acids.Materials#: 305167 batch#: 2228394.It was reported by the customer that defect in the needle coating, a cut in the needle coating.Verbatim: defect in the needle coating, a cut in the needle coating.

• Brand Name: NEEDLE 21X1-1/2 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; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18303469
• Report Number: 1911916-2023-00890
• Device Sequence Number: 15019456
• Product Code: FMI
• UDI-Device Identifier: 30382903051671
• UDI-Public: (01)30382903051671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/04/2024

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: 305167
• Device Lot Number: 2228394
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown