MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® Z; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365963
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd microtainer® z there was poor barrier separation of the sample.The following information was provided by the initial reporter.The customer stated: "the sample is not spinning properly during centrifugation and has to be spin multiple times in order for the sample to separate properly.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, issues relating to poor serum were observed.Bd was able to duplicate the customer¿s indicated failure mode, poor serum, because the defect was evident in the testing of the complaint lot samples.Visual evaluations of both complaint lot (retains) and control samples poor serum for all visual observations evaluated.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 has been confirmed for the indicated failure mode poor serum.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to poor serum were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.
Event or Problem Description
It was reported when using the bd microtainer® z there was poor barrier separation of the sample.The following information was provided by the initial reporter.The customer stated: "the sample is not spinning properly during centrifugation and has to be spin multiple times in order for the sample to separate properly.".

• Brand Name: BD MICROTAINER® Z
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16162213
• Report Number: 2618282-2023-00004
• Device Sequence Number: 17893867
• Product Code: JKA
• UDI-Device Identifier: 50382903659635
• UDI-Public: 50382903659635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/28/2023

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: 11/30/2023
• Device Model Number: 365963
• Device Catalogue Number: 365963
• Device Lot Number: 2151029
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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