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

Model Number	366594
Medical Device Problem Codes	Retraction Problem (1536); Defective Component (2292); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 2243072-2022-01470
• Device Sequence Number: 12068989
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: 50382903665940
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 09/12/2022

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 Expiration Date: 03/31/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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