MAUDE Adverse Event Report: BECTON DICKINSON BD SAFETY LANCET

Catalog Number 369528

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: w47l640a4.Medical device expiration date: 01/31/2021.Device manufacture date: 01/06/2016.Medical device lot #: w47m540b2.Medical device expiration date: 02/28/2021.Device manufacture date: 02/29/2016.Initial reporter: address unavailable.Bd corporate address used.Results - bd received three samples and two photos from the customer facility for investigation.Two samples and two photos were evaluated and the customer's indicated failure mode for missing caps with the incident lot was observed.The third sample had a correctly twisted and removed needle cap, as if it was prepared for use.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for missing caps was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Mechanical defects are established at aql = 1 and are defined in product specifications as parameter "aesthetics and correctness of assembly".Conclusion - based on the above, bd decides not to undertake corrective actions related to the complaint but undertakes to monitor occurrence of the defect.

Event Description

It was reported that after opening a package of bd safety lancet, 3 units had detached needle covers.No injury or medical intervention reported.

• Brand Name: BD SAFETY 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: 7058917
• MDR Text Key: 93450157
• Report Number: 2243072-2017-00273
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 369528
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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