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

Catalog Number	365963
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
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 that tubes were not clotting after use with a bd microtainer® z (no additive tubes).The following information was provided by the initial reporter: material no: 365963.Batch no:8155792.(1 of 2).It was reported the customer was experiencing tubes not clotting.Found out about the recall after experiencing issues.This has been occurring for a couple weeks, no specific dates known.
Event or Problem Description
It was reported that tubes were not clotting after use with a bd microtainer® z (no additive tubes).The following information was provided by the initial reporter: material no: 365963 batch no:8155792 (1 of 2).It was reported the customer was experiencing tubes not clotting.Found out about the recall after experiencing issues.This has been occurring for a couple weeks, no specific dates known.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to samples not clotting, as all samples met specifications.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.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for samples not clotting with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• 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: 8697259
• Report Number: 2618282-2019-00198
• Device Sequence Number: 16555118
• Product Code: JKA
• UDI-Device Identifier: 50382903659635
• UDI-Public: 50382903659635
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (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): 07/08/2019

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: 11/30/2019
• Device Catalogue Number: 365963
• Device Lot Number: 8155792
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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