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	03/06/2020
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 are not separating after centrifugation with an bd microtainer® sst¿ amber.The following information was provided by the initial reporter: we have been having issues with our serum separator microtainers that we use for neonatal bilirubin's.We are centrifuging them for 10 min at 3000 rpm and they are not separating.We will only get maybe a drop of serum out, so we centrifuge them again for the 10 min at 3000 and most of the time then are ok then.Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: spoke with the customer and explained that she is not centrifuging the microtainers at the correct speed and time.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.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.H3 other text : see h.10.
Event or Problem Description
It was reported that tubes are not separating after centrifugation with an bd microtainer® sst¿ - (b)(6).The following information was provided by the initial reporter: we have been having issues with our serum separator microtainers that we use for neonatal bilirubin's.We are centrifuging them for 10 min at 3000 rpm and they are not separating.We will only get maybe a drop of serum out, so we centrifuge them again for the 10min at 3000 and most of the time then are ok then.Additionally, on 2020-03-06 the bd sales consultant provided the following additional information: spoke with the customer and explained that she is not centrifuging the microtainers at the correct speed and time.

• 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: 9884614
• Report Number: 2618282-2020-00031
• Device Sequence Number: 2561071
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: Other
• Device Expiration Date: 06/30/2020
• Device Model Number: 365978
• Device Catalogue Number: 365978
• Device Lot Number: 9092725
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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