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

Catalog Number 366594

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results - bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for broken blades with the incident lot was not observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for broken blades was not observed as all samples met specifications.Needle points from the sample were visually inspected at x10.No defects were observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - bd was not able to duplicate or confirm the customers indicated failure mode.

Event Description

It was reported that the blade of a bd microtainer® contact-activated lancet broke off and remained in a patient for 3 days.It required the nurse to squeeze the blade out and treat the wound with peroxide.No serious injury reported.Medical intervention unknown.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• 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: 7075816
• MDR Text Key: 94210684
• Report Number: 2243072-2017-00276
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 00382903665945
• UDI-Public: 00382903665945
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 366594
• Device Lot Number: W3A62F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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