MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET 1.5 MM BLADE; AUTO LANCET

Catalog Number 366594

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: on (b)(6) 2017 four lancets from batch #w3c58l7 were delivered.Three lancets were new/unused and the one defective lancet had the cover attached with tape.The needle was found in the cap separated from the device.A review of the device history record revealed that one device was out of specification.Retention samples were evaluated and found to be within specification requirements.Conclusion: customers defect was confirmed as per the returned sample and device history record.(b)(4).

Event Description

It was reported that the bd microtainer® contact-activated lancet separated from the housing device during use.There was no report of medical intervention.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET 1.5 MM BLADE
• Type of Device: AUTO LANCET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6770343
• MDR Text Key: 82125927
• Report Number: 2243072-2017-00069
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 366594
• Device Lot Number: W3C58L7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other