MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE ¿ 3 NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303262
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd microlance ¿ 3 needle was blocked.The following information was provided by the initial reporter, translated from french to english: blocked needle.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd microlance ¿ 3 needle was blocked.The following information was provided by the initial reporter, translated from french to english: blocked needle.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided material number 303262 and lot numbers 221110 and 221112.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, (b)(4) retained samples were obtained for evaluation from the manufacturing facility.The retained samples were used to puncture a test vial and were then examined microscopically; however, no signs of defect were identified.Based on the provided feedback, we understand an issue related to clogged needle took place, possibly due to coring.However, based on the investigation results and the preventive measures in place, an exact manufacturing related cause could not be determined for this event.Material 303262 has been created with a regular bevel, compared to material 304622 which had a short bevel.This means that the needle needs to puncture the vial differently.Material 303262 should puncture the vial at an angle of penetration between 45 to 60 degrees.

• Brand Name: BD MICROLANCE ¿ 3 NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17572885
• Report Number: 3002682307-2023-00254
• Device Sequence Number: 8268078
• Product Code: FMI
• UDI-Device Identifier: 30382904487431
• UDI-Public: 30382904487431
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 09/13/2023

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: Other
• Device Catalogue Number: 303262
• Device Lot Number: 221112
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown