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

Model Number 366594

Device Problems Retraction Problem (1536); Defective Component (2292); Improper Flow or Infusion (2954)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.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 when using the bd microtainer® contact-activated lancet lancet did not activate, the needle was not recovered.This event occurred 200 times.The following information was provided by the initial reporter.The customer stated: "during using the lancet, it was found that the lancet did not activate, the needle was not recovery, and occurred insufficient blood flow issue.Patients and users were not affected.".

Event Description

It was reported when using the bd microtainer® contact-activated lancet lancet did not activate, the needle was not recovered.This event occurred 200 times.The following information was provided by the initial reporter.The customer stated: "during using the lancet, it was found that the lancet did not activate, the needle was not recovery, and occurred insufficient blood flow issue.Patients and users were not affected.".

Manufacturer Narrative

H.6.Investigation summary: material # 366594.Lot/batch # b7b82d4.Bd received 10 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure modes for does not activate/does not recover/insufficient blood flow with the incident lot was not observed.Additionally, retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to does not activate/does not recover/insufficient blood flow 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 modes.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• 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: 15358920
• MDR Text Key: 303744869
• Report Number: 2243072-2022-01470
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: 50382903665940
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• 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: B7B82D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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