MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET

Catalog Number 369528

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Date received by manufacturer is unknown.Date sent to manufacturer has been used for this field.Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for damaged lancet during assembly with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for damaged lancet was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd was able to confirm customer's indicated failure mode.During normal operation of the assembly machine, there can be rare instances of component damage.

Event Description

It was reported that when removing orange cap from the bd microtainer® contact-activated lancet, the orange button and the needle came off at the same time then flew to backward.Customer threw away the needle.Bdj received white holder and orange button.There was no report of serious injury or medical intervention that occurred as a result of this incident.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Type of Device: 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: 7100423
• MDR Text Key: 94820998
• Report Number: 2243072-2017-00258
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 369528
• Device Lot Number: V47H340B3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other