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

Model Number 366594

Device Problems Break (1069); Material Fragmentation (1261); Separation Problem (4043)

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

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.

Manufacturer Narrative

H6: investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure modes with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to did not retract/metal left in finger as all samples met specifications.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.This complaint is unable to be confirmed for the indicated failure modes.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd microtainer® contact-activated lancet the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.

Manufacturer Narrative

Imdrf annex a code changed from a1503 to a0401.

Event Description

It was reported when using the bd microtainer® contact-activated lancet the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.

• 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: 16010026
• MDR Text Key: 307011180
• Report Number: 2243072-2022-02184
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: C3K11C4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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