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

Model Number	366592
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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 nipro, thailand is an oem manufacturing site.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd microtainer® contact-activated lancet cap was found detached before use.The following information was provided by the initial reporter: according to the customer's report, the cap was found to be detached before usage.
Additional Manufacturer Narrative
H.6.Investigation summary: "bd received 99 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for loose cap with the incident lot was observed in 1 of the samples.The sample with the loose cap was disassembled to assess interior components and a deformed lever was found, leading to the loose cap.Additionally, retention samples from bd inventory were evaluated by visual examination and the issue of loose cap was not 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 loose cap.Bd was not able to identify a root cause for the indicated failure mode." the following fields were updated due to additional information: d9: device available for evaluation:  yes; d9: returned to manufacturer on: 2023-06-14.H3 other text : see h.10.
Event or Problem Description
It was reported that bd microtainer® contact-activated lancet cap was found detached before use.The following information was provided by the initial reporter: according to the customer's report, the cap was found to be detached before usage.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16992174
• Report Number: 2243072-2023-00860
• Device Sequence Number: 17888533
• Product Code: FMK
• UDI-Device Identifier: 50382903665926
• UDI-Public: 50382903665926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/14/2023

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 Model Number: 366592
• Device Catalogue Number: 366592
• Device Lot Number: C9C38K4
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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