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

Model 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	01/09/2020
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 that there was poor barrier separation after use with a bd microtainer® sst¿ - amber.The following information was provided by the initial reporter: it is reported by customer one vacutainer experienced poor barrier separation.Additional information received 2020-01-10 from customer: she states that the microtainer was a heelstick draw by a nurse on the ob floor from a (b)(6) baby.She is not certain if the nurse mixed the tube.It was spun in a drucker apex 6 at 5306 rpm for 3 minutes, then again for 5 minutes, with poor separation, and then spun in a thermofisher centrifuge at 3200 rpm for 10 minutes.At this point, there was enough serum to run the bilirubin test.They usually don't have problems with microtainer samples, and usually separate well after the first spin.I explained that it is important to mix the tubes once they are collected, since there is clot activator in the tube, and to centrifuge at 6000 - 15,000 g for 90 seconds.
Additional Manufacturer Narrative
Investigation summary bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for sample quality with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed relating to sample quality 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.
Event or Problem Description
It was reported that there was poor barrier separation after use with a bd microtainer® sst¿ - amber.The following information was provided by the initial reporter: -it is reported by customer one vacutainer experienced poor barrier separation.Additional information received 2020-01-10 from customer: she states that the microtainer was a heelstick draw by a nurse on the ob floor from a 3 day old baby.She is not certain if the nurse mixed the tube.It was spun in a drucker apex 6 at 5306 rpm for 3 minutes, then again for 5 minutes, with poor separation, and then spun in a thermofisher centrifuge at 3200 rpm for 10 minutes.At this point, there was enough serum to run the bilirubin test.They usually don't have problems with microtainer samples, and usually separate well after the first spin.I explained that it is important to mix the tubes once they are collected, since there is clot activator in the tube, and to centrifuge at 6000 - 15,000 g for 90 seconds.

• 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: 9644697
• Report Number: 2618282-2020-00002
• Device Sequence Number: 2495262
• Product Code: JKA
• UDI-Device Identifier: 50382903659789
• UDI-Public: 50382903659789
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 365978
• Device Catalogue Number: 365978
• Device Lot Number: 9038763
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/25/2020
• 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