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

Catalog Number	366592
Medical Device Problem Codes	Product Quality Problem (1506); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported the bd microtainer® contact-activated lancet had the protective cap comes off letting needle/blade exposed and possible clean needle stick/injury before use.The following information was provided by the initial reporter: the customer stated: ¿customer reported that the cap of the blade had been separated from the device before use.
Additional Manufacturer Narrative
Investigation summary bd received 1 sample and 3 photos from the customer for investigation.The photos were reviewed and the indicated failure mode for missing cap with the incident lot was observed.Additionally, the customer sample was evaluated by visual examination and the issue of missing cap was observed.Retention samples from bd inventory were evaluated by visual examination and the issue of missing 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 non-conformances during manufacturing of the product.H3 other text : see h.10.
Event or Problem Description
It was reported the bd microtainer® contact-activated lancet had the protective cap comes off letting needle/blade exposed and possible clean needle stick/injury before use.The following information was provided by the initial reporter: the customer stated: ¿customer reported that the cap of the blade had been separated from the device 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
• MDR Report Key: 10339912
• Report Number: 2243072-2020-01156
• Device Sequence Number: 3842725
• Product Code: FMK
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 12/31/2024
• Device Catalogue Number: 366592
• Device Lot Number: A9M59A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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