MAUDE Adverse Event Report: BECTON DICKINSON BD¿ LANCET CONT-ACT BLUE 1.5MM X 2.0MM

Catalog Number 366594

Device Problem Material Separation (1562)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle from a bd¿ lancet 1.5mm x 2.0mm remained in the middle finger of a patient after having blood drawn on (b)(6) 2017.On (b)(6) 2017, while the patient was volunteering at a medical facility, she notice discomfort so she visited the occupational medical service center at that facility.A nurse reported there was something in her finger.Upon squeezing the finger, the nurse was able to remove the needle from her finger.Once removed, the nurse applied peroxide and neosporin.No further medical intervention was needed.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for the blade breaking off with the incident lot was not observed.Additionally, retention samples were selected from inventory for testing and upon completion, the customer's indicated failure mode was not observed as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for the blade breaking off with the incident lot was not observed as all samples met the required specifications.Root cause: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.

• Brand Name: BD¿ LANCET CONT-ACT BLUE 1.5MM X 2.0MM
• 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: 6985540
• MDR Text Key: 91136962
• Report Number: 2243072-2017-00205
• 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: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 366594
• Device Lot Number: W3A62F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• 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