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

Catalog Number	366594
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet, the device experienced lancet breaks off.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the lancet had tip broken after blood collection.One of the lead's proceeded to poke herself with one of the new lancets and it left a shard of metal in her finger stating that the new needles are larger than the previous."my lead obtained a blood sugar on a patient with one of the new lancets and the patient complained of pain and it bled much more than normal.My lead was curious so she poked herself with a new one and it left a shard of metal in her finger.The size of these new needles are much larger than the previous." customer problem: customer reports a lancet with the tip broken off after blood collection.A small piece of metal broke off from the tip of the lancet during blood collection.Did exposure to blood/ bf occur? no if exposure occurred was there any post exposure testing or medical intervention? n/a.
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed in sections as html is an (b)(6) manufacturing site.Medical device expiration date: unknown initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.Device manufacture date: unknown investigation summary: material #366594 lot/batch # unknown bd had not received samples, but 3 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for broken with the unknown incident lot was not observed.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.Bd manufactures several millions of safety lancets each and every day with the most comprehensive quality assurance procedures to meet the highest standards.We would like to stress that our product meets all applicable standards.There is a significant role of health care provider to select the lancet with proper size of needle in regard to patient need and required size of blood sample.Bd has three types of lancets that give different blood flow: purple low <10 ¿l 1.5mm, 30g/0.30mm, pink 100 - 250 ¿l 1.8mm, 21g/0.81mm and blue 250 ¿ 500 ¿l 2.0mm, 17g/1.5mm.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: 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: 14627143
• Report Number: 2243072-2022-00768
• Device Sequence Number: 4456361
• Product Code: FMK
• UDI-Device Identifier: 00382903665945
• UDI-Public: 00382903665945
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 366594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown