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

Catalog Number	303262
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd microlance ¿ 3 needles it gets clogged.The following was received from the initial reporter: we sometimes use 3 or 4 trocars to inject into the iv because it gets clogged.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 303262 and lot number 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, twenty (20) retained samples were obtained from the manufacturing facility.The needles were visually examined and no defects were identified.The needles were then used to puncture a test vial and were examined microscopically with no defects observed.Based on the provided feedback, it is understood that a coring issue took place, causing needle clogging.Based on the preventive measures in place, it is unlikely that coring resulted from poor or insufficient de-burring of the cannula.We would like to inform you that new material 303262 has a regular bevel in comparison to material 304322 which had a short bevel.This means that the way the needle punctures the vial changes.For material 303262, the angle of penetration for the vial should be between 45 to 60 degrees.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
It was reported that while using the bd microlance ¿ 3 needles it gets clogged.The following was received from the initial reporter: we sometimes use 3 or 4 trocars to inject into the iv because it gets clogged++.

• Brand Name: BD MICROLANCE ¿ 3 NEEDLES
• 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: 17515348
• Report Number: 3002682307-2023-00247
• Device Sequence Number: 14836679
• Product Code: FMI
• UDI-Device Identifier: 30382904487431
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 303262
• Device Lot Number: 221112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/22/2023
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown