MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH LH; NON-EVACUATED BLOOD COLLECTION TUBE IVD

Catalog Number	365965
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	12/26/2018
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 a bd microtainer® tubes with lh did not separate properly.
Additional Manufacturer Narrative
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 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.Bd technical services had provided troubleshooting and guidance to the customer.The customer had requested centrifugation information as they noted they had a fixed angle centrifuge on site with limited ability to adjust speed.Bd had recommended a time/speed of 90 seconds at 6000-15000g's as indicated in the product instructions for use (ifu).The customer stated that their centrifuge is not capable of reaching the required speed as indicated in the ifu.Bd will continue to monitor if the customer requires any additional support.Investigation conclusion: based on evaluation of the retain samples, 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 a bd microtainer® tubes with lh did not separate properly.

• Brand Name: BD MICROTAINER® TUBES WITH LH
• Common Device Name: NON-EVACUATED BLOOD COLLECTION TUBE IVD
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8242138
• Report Number: 2618282-2018-00085
• Device Sequence Number: 2701622
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• 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
• Report Date (Section B): 04/03/2019

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: 07/31/2019
• Device Catalogue Number: 365965
• Device Lot Number: 803067N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/04/2019
• 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