MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER Z (NO ADDITIVE TUBES); BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365963
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported during use the bd microtainer® z (no additive tubes) had incorrect additive and clotting / micro-clots/fibrin clots (tubes that are not supposed to clot) the following information was provided by the initial reporter: "edta or strek solution was added to the tube but it was still clotted".
Event or Problem Description
It was reported during use the bd microtainer® z (no additive tubes) had incorrect additive and clotting / micro-clots/fibrin clots (tubes that are not supposed to clot) the following information was provided by the initial reporter: "edta or strek solution was added to the tube but it was still clotted".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to sample quality was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
Event or Problem Description
It was reported during use the bd microtainer® z (no additive tubes) had incorrect additive and clotting / micro-clots/fibrin clots (tubes that are not supposed to clot) the following information was provided by the initial reporter: "edta or strek solution was added to the tube but it was still clotted".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to sample quality was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on the investigation, a root cause could not be determined.

• Brand Name: BD MICROTAINER Z (NO ADDITIVE TUBES)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9811814
• Report Number: 2618282-2020-00018
• Device Sequence Number: 3267720
• Product Code: JKA
• UDI-Device Identifier: 50382903659635
• UDI-Public: 50382903659635
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• 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,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: 365963
• Device Catalogue Number: 365963
• Device Lot Number: 9158564
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020; 06/20/2021
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/13/2020; 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other