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

Model Number	366594
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.Investigation summary: material # 366594, lot/batch # unknown, bd had not received samples or photos from the customer for evaluation.Additionally, 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.Pain and skin reactions are a subjective patient feeling, bd is not able to confirm or not confirm the complaint.According to ifu, it is important to keep in mind that pain is a subjective feeling that differs across individuals and situations.Many important factors are to help minimize the pain during puncture.Bd is aware of unique patient circumstances.It is recommended to do the puncture on site of third (middle) or fourth (ring) finger not on the tip and to switch the fingers regularly.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.Oem manufacture: the manufacturing location for this product is (high tech labs).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet hcp was curious and poked herself with a new lancet, and it left a shard of metal in her finger.The following information was provided by the initial reporter.The customer stated: "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.".

• 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: 14633716
• Report Number: 2243072-2022-00773
• Device Sequence Number: 20306788
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: 50382903665940
• 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): 05/20/2022

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 Model Number: 366594
• 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: 06/08/2022
• 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