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

Catalog Number	366593
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during use with 2 bd microtainer® contact-activated lancet the lancet pulled out of the device.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: on october 10, the teacher of the outpatient laboratory department informed that there was a quality problem in the process of collecting peripheral blood.When i went to the scene, i found that when a needle was opened, it was in a broken state, and the pink part had a defect similar to melting, and it fell apart after holding it.When a needle is used, it is directly pulled out together with the puncture needle, and the puncture needle pulled out at the same time is the tip is exposed, and it is suspected that the puncture needle is installed backwards.The scene and the teacher disassembled a normal blood collection device for comparison, and found that the puncture needle in question was indeed installed backwards, please help confirm this problem.The needle was pulled out and installed backwards.
Additional Manufacturer Narrative
H.6 investigation summary material #: 366593.Lot/batch #: c4h39h2.Bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to damaged housing or incorrect blade assembly 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 damaged housing and incorrect blade assembly.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.
Event or Problem Description
It was reported that during use with 2 bd microtainer® contact-activated lancet the lancet pulled out of the device.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: on october 10, the teacher of the outpatient laboratory department informed that there was a quality problem in the process of collecting peripheral blood.When i went to the scene, i found that when a needle was opened, it was in a broken state, and the pink part had a defect similar to melting, and it fell apart after holding it.When a needle is used, it is directly pulled out together with the puncture needle, and the puncture needle pulled out at the same time is the tip is exposed, and it is suspected that the puncture needle is installed backwards.The scene and the teacher disassembled a normal blood collection device for comparison, and found that the puncture needle in question was indeed installed backwards, please help confirm this problem.The needle was pulled out and installed backwards.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17999219
• Report Number: 2243072-2023-01921
• Device Sequence Number: 12292953
• Product Code: FMK
• UDI-Device Identifier: 50382903665933
• UDI-Public: (01)50382903665933
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223243
• 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): 11/30/2023

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 Catalogue Number: 366593
• Device Lot Number: C4H39H2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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