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

Catalog Number	301300
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microlance¿3 needles foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: one hair was shrink-wrapped in two sterile packages.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd microlance¿3 needles foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: one hair was shrink-wrapped in two sterile packages.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report 3002682307-2023-00125 was sent in error.(foreign matter visible on noninvasive components of needle (hub, needle shield) is not considered to be a reportable malfunction.Mfr#: 3002682307-2023-00125 is void as a result.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16951004
• Report Number: 3002682307-2023-00125
• Device Sequence Number: 3339969
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: (01)00382903058914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 301300
• Device Lot Number: 220927
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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