MAUDE Adverse Event Report: BD CARIBE LTD. BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE; CAPILLARY BLOOD COLLECTION TUBE IVD

Catalog Number	366604
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: lot 4012385 is a non-commercial lot manufactured for experimental use that expired on 30sep24.Bd does not recommend the use of product after the expiration date.Bd had not received samples or photos for investigation.Therefore, 45 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to hemolysis as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode hemolysis.Bd was not able to identify a root cause for the indicated failure mode.The bd instructions for use includes caution statements to not shake the tube during mixing and to not drop, roll or hold the tube in a horizontal position as this may impact sample quality.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.
Event or Problem Description
It was reported when using the bd minidraw¿ sst¿ capillary blood collection tube, one blood sample was hemolyzed and needed to be recollected.There were no other health consequences or impacts reported.

• Brand Name: BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE
• Common Device Name: CAPILLARY BLOOD COLLECTION TUBE IVD
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20762212
• Report Number: 2618282-2024-00171
• Device Sequence Number: 9264317
• Product Code: JKA
• UDI-Device Identifier: 00382903666041
• UDI-Public: (01)00382903666041(11)240112(17)240930(10)4012385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230391
• 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): 11/14/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 366604
• Device Lot Number: 4012385
• 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: 11/05/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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