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

Catalog Number	366593
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with an unspecified amount of bd microtainer® contact-activated lancet foreign matter was discovered on device.The following information was provided by the initial reporter, translated from japanese to english: complaint details: black spots, stains.
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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: c4f19e7, d.4.Medical device expiration date: 30-apr-2027, h.4.Device manufacture date: 22-jul-2022, d.4.Medical device lot #: c4j58e9, d.4.Medical device expiration date: 13-jul-2027, h.4.Device manufacture date: 14-oct-2022, d.4.Medical device lot #: c4j68e8, d.4.Medical device expiration date: 17-jul-2027, h.4.Device manufacture date: 14oct-2022.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 an unspecified amount of bd microtainer® contact-activated lancet foreign matter was discovered on device.The following information was provided by the initial reporter, translated from japanese to english: complaint details: black spots, stains.
Additional Manufacturer Narrative
D.10 device available for eval? yes d.10 returned to manufacturer on: 11-sep-2023 h.6.Investigation summary: bd received 400 samples for investigation.The samples were evaluated by visual examination and the following failure modes were observed for each reported lot number: lot number c4f19e7 had 7 samples with foreign matter, 10 with a damaged shield, and 1 with a molding defect.Lot number c4j58e9 had 5 samples with foreign matter and 11 with a damaged shield.Lot number c4j68e8 had 10 samples with foreign matter, 8 with a damaged shield, and 7 with molding defects.Additionally, retention samples from bd inventory of each reported lot number were evaluated by visual examination and the following failure modes were observed for each reported lot number: lot number c4f19e7 had 1 retention samples with a damaged shield.Lot number c4j58e9 had 4 retention samples with foreign matter.Lot number c4j68e8 had 3 retention samples with a damaged shield and 1 with foreign matter.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 modes foreign matter, damaged shield, and molding defects.Bd has initiated further root cause investigation relating to the issues of foreign matter, damaged shield, and molding defects through corrective and preventive actions.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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17804769
• Report Number: 2243072-2023-01706
• Device Sequence Number: 17986795
• Product Code: FMK
• UDI-Device Identifier: 50382903665933
• UDI-Public: 50382903665933
• 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): 10/04/2023

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: SEE H.10
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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