MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 366593

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As htl is an oem manufacturing site.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that prior to use with 2 bd microtainer® contact-activated lancet the protective cap is loose and falls off.The following information was provided by the initial reporter, translated from japanese to english: cap off.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 2243072-2023-01719 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that prior to use with 2 bd microtainer® contact-activated lancet the protective cap is loose and falls off.The following information was provided by the initial reporter, translated from japanese to english: cap off.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17818590
• MDR Text Key: 324275705
• Report Number: 2243072-2023-01719
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 50382903665933
• UDI-Public: 50382903665933
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K223243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 366593
• Device Lot Number: C4F21D2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1