MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® CONTACT-ACTIVATED LANCET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365967
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd microtainer® sst¿ tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The tubes are underfilling.From a bd sponsored clinical trial, the specimen stopped flowing into tube.Customer stated the specimen was below the bottom fill line.There was no reported patient adverse event(s).
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Product information has been updated and this mfr.Report # 2618282-2022-00071 was deemed not reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.This type of event renders the device unusable prior to use, requiring replacement.There is no exposure to blood.H3 other text: see h10.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The tubes are underfilling.From a bd sponsored clinical trial, the specimen stopped flowing into tube.Customer stated the specimen was below the bottom fill line.There was no reported patient adverse event(s).

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; k.m. 24.3; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15719475
• Report Number: 2618282-2022-00071
• Device Sequence Number: 14183026
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: (01)50382903665940
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/30/2022
• Device Model Number: 365967
• Device Catalogue Number: 366594
• Device Lot Number: B7D62G2
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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