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

Model Number 366594

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.(b)(4).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 when using the bd microtainer® contact-activated lancet there was foreign matter.This event occurred 24 times.The following information was provided by the initial reporter.The customer stated: ¿the customer reported the following issues of lancet (cat#366594).(1) damaged shield (blue component) ×1, (2) damaged/cracked housing (white component) ×4, (3) fm (dirt) ×24, photos are attached in "attachment(s).".

Manufacturer Narrative

H.6.Investigation summary: "bd received samples and photos for investigation.The photos were reviewed and the indicated failure modes for damaged shield/damaged housing/foreign matter were observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated by visual examination and the issues of damaged shield/damaged housing/foreign matter were observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product." d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-12-19.

Event Description

It was reported when using the bd microtainer® contact-activated lancet there was foreign matter.This event occurred 24 times.The following information was provided by the initial reporter.The customer stated: ¿the customer reported the following issues of lancet (cat#366594).(1) damaged shield (blue component) ×1.(2) damaged/cracked housing (white component) ×4.(3) fm (dirt) ×24.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15839106
• MDR Text Key: 307628954
• Report Number: 2243072-2022-02004
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: 50382903665940
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 366594
• Device Catalogue Number: 366594
• Device Lot Number: B3F12J8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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