MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	363706
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown, d4.Medical device expiration date: unknown, h4.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported after collecting blood in bd microtainer® map microtubes for automated process k2 edta 1.0 mg, the blood samples were clotted when the lab went to analyze them.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report #: 2618282-2024-00145 was submitted with an incorrect site legal name and manufacturing location.The correct site legal name is becton, dickinson & co.- broken bow, ne / 68822.A new initial mdr will be submitted in reference to this report, correcting the site legal name and manufacturing location.Mfr report #: 2618282-2024-00145 is now considered void.
Event or Problem Description
It was reported after collecting blood in bd microtainer® map microtubes for automated process k2 edta 1.0 mg, the blood samples were clotted when the lab went to analyze them.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.

• Brand Name: BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20376406
• Report Number: 2618282-2024-00145
• Device Sequence Number: 11698852
• Product Code: JKA
• UDI-Device Identifier: 30382903637066
• UDI-Public: (01)30382903637066
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093972
• 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,Followup
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 363706
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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