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

Catalog Number	366592
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is htl.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: bd received 4 samples and 4 photos for investigation.The photos were reviewed and the indicated failure mode for cap separation was observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated by visual examination and functional testing and the issue of cap separation was 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.This complaint has been confirmed for the indicated failure mode cap separation.Bd determined that the root cause of the indicated failure mode was attributed to low force of removing the tab cap from the needle shield, which may be due to: exceeded upper tolerance dimension in the needle tip due to wear of the forming tools or a misaligned process or exceeded lower dimensions on the complete needle as a result of wear of the forming tools or an incorrectly set process.Bd has already initiated corrective actions.Therefore, no additional action will be undertaken.The claimed batch number was produced before the activities were fully implemented.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet the protective cap comes off leaving the needle/blade exposed.The following information was provided by the initial reporter.The customer stated: "the cap was found to be detached for one products before use.".

• 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: 15131607
• Report Number: 2243072-2022-01021
• Device Sequence Number: 5498992
• Product Code: FMK
• UDI-Device Identifier: 50382903665926
• UDI-Public: 50382903665926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/01/2022

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: 02/28/2026
• Device Catalogue Number: 366592
• Device Lot Number: B9B18B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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