MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® SST¿ - AMBER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365978
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	01/01/2019
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 and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that after use of the bd microtainer® sst¿ amber the tube is clotting and hemolyzing.
Event or Problem Description
It was reported that after use of the bd microtainer® sst¿ amber the tube is clotting and hemolyzing.
Additional Manufacturer Narrative
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 and no issues were observed and all retention 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.Hemolysis can be caused by many sources, including certain patient pathological conditions, improper specimen collection, specimen processing, and specimen transport.Specimen processing factors include vigorous mixing or shaking of the specimen, not allowing the specimen to clot for the recommended amount of time, prolonged contact of serum or plasma with cells, and exposure to excessive heat or cold.Finally, mechanical trauma and other adverse conditions during transport of tubes can result in hemolysis.Investigation conclusion: based on evaluation of the retain samples, no issues were observed and all retention samples met 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.

• Brand Name: BD MICROTAINER® SST¿ - AMBER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8257493
• Report Number: 2618282-2019-00002
• Device Sequence Number: 19194626
• Product Code: JKA
• UDI-Device Identifier: 50382903659789
• UDI-Public: 50382903659789
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/26/2019

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: 09/30/2019
• Device Catalogue Number: 365978
• Device Lot Number: 8207774
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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