MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD MICROTAINER® LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2022

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Oem manufacturer:(b)(4).

Event Description

It was reported when using the unknown bd microtainer® lancet broke off and remained embedded in her finger for several days.The following information was provided by the initial reporter.The customer stated: "material no.Unknown, batch no.Unknown.It was reported by the customer that the lancet broke off and remained embedded in her finger for several days.".

Manufacturer Narrative

The following fields were updated due to device evaluation: h.6.Investigation summary: material # unknown.Lot/batch # unknown.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for broke off was not observed.In addition, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported when using the unknown bd microtainer® lancet lancet broke off and remained embedded in her finger for several days.The following information was provided by the initial reporter.The customer stated: "material no.Unknown batch no.Unknown it was reported by the customer that the lancet broke off and remained embedded in her finger for several days.".

• Brand Name: UNKNOWN BD MICROTAINER® LANCET
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14861516
• MDR Text Key: 302945252
• Report Number: 2243072-2022-00879
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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