MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER CONTACT-ACTIVATED LANCET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366592
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is high tech labs.This site is an oem manufacturing site.(b)(4).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 a bd microtainer® contact-activated lancet shield was detached.
Event or Problem Description
It was reported that a bd microtainer® contact-activated lancet shield was detached.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for improper assembly with the incident lot was not observed, while the failure mode relating to discoloration was observed to be a molding issue.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed for either failure mode.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for improper assembly was not observed; however, we observed the discoloration to be attributed to a molding issue.Evaluation/testing of the retained samples was also conducted and no issues were observed.Root cause description: based on the investigation, the most likely root cause of the molding issue was determined to be related to a manufacturing incident.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROTAINER CONTACT-ACTIVATED LANCET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8174464
• Report Number: 2243072-2018-01858
• Device Sequence Number: 1203228
• Product Code: FMK
• UDI-Device Identifier: 00382903665921
• UDI-Public: 382903665921
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 366592
• Device Lot Number: Y9B82E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other