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	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that bd microtainer® sst¿ - amber had poor separator movement.This occurred on 3 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: part no.: 365978.Batch/lot: 8208542.It was reported that the "gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum." original text: tubes were spun before sending to lab.Collected at one site and sent another for testing.Two of the specimens spun and sent out with a courier several hours later.One specimen spun and sent out stat so that one was able to be respun and tested.Gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum.
Event or Problem Description
It was reported that bd microtainer® sst¿ - amber had poor separator movement.This occurred on 3 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: part no.: 365978.Batch/lot: 8208542.It was reported that the "gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum.".Original text: tubes were spun before sending to lab.Collected at one site and sent another for testing.Two of the specimens spun and sent out with a courier several hours later.One specimen spun and sent out stat so that one was able to be respun and tested.Gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for poor barrier separation with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to poor barrier separation 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 customer and retain samples, the customer¿s indicated failure mode for poor barrier separation 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 product was found to be in conformance and meet release specifications.Rationale: 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.
Additional Manufacturer Narrative
H.6.Investigation: 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 and upon completion, no issues were observed relating to poor barrier separation 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 poor barrier separation 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.Rationale: 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.
Event or Problem Description
It was reported that bd microtainer® sst¿ - amber had poor separator movement.This occurred on 3 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: part no.: 365978.Batch/lot: 8208542.It was reported that the "gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum.".Original text: tubes were spun before sending to lab.Collected at one site and sent another for testing.Two of the specimens spun and sent out with a courier several hours later.One specimen spun and sent out stat so that one was able to be respun and tested.Gel is sitting at the bottom of tube after spinning and not migrating to separate red cells from serum.

• 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: 8535950
• Report Number: 2618282-2019-00161
• Device Sequence Number: 18925803
• Product Code: JKA
• UDI-Device Identifier: 50382903659789
• UDI-Public: 50382903659789
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/04/2019

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: 8208542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019; 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/07/2019; 06/04/2019
• 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