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	05/02/2019
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
Material no.: 365978.Batch/lot: 8262866.It was reported that during use of the bd microtainer® sst¿ - amber "two different specimens were collected and spun -- gel did not migrate on either specimen after first spin".The following information was provided by the initial reporter: customer text: 2 microtainer tubes collected.One tube migrated and one did not.Lot: 8262866 exp: 11/30/2019.Two different specimens were collected and spun -- gel did not migrate on either specimen after first spin.So both specimens immediately spun a second time - one of them migrated and one did not.Specimen that did not migrate was spun a third and a fourth time and still did not migrate.
Additional Manufacturer Narrative
Investigation: investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for gel migration 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 gel migration 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 gel not migrating 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.
Event or Problem Description
Material no.: 365978.Batch/lot: 8262866.It was reported that during use of the bd microtainer® sst¿ amber "two different specimens were collected and spun gel did not migrate on either specimen after first spin".The following information was provided by the initial reporter: customer text: 2 microtainer tubes collected.One tube migrated and one did not.Lot: 8262866 exp: 11/30/19.Two different specimens were collected and spun gel did not migrate on either specimen after first spin.So both specimens immediately spun a second time - one of them migrated and one did not.Specimen that did not migrate was spun a third and a fourth time and still did not migrate.
Additional Manufacturer Narrative
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/testing and upon completion, no issues were observed relating to the additive and barrier gel attributes 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 gel failing to migrate 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
Material no.: 365978.Batch/lot: 8262866.It was reported that during use of the bd microtainer® sst¿ - amber "two different specimens were collected and spun gel did not migrate on either specimen after first spin".The following information was provided by the initial reporter: customer text: 2 microtainer tubes collected.One tube migrated and one did not.Lot: 8262866 exp: 11/30/19 two different speciments were collected and spun gel did not migrate on either speciment after first spin.So both speciments immediately spun a second time - one of them migrated and one did not.Speciment that did not migrate was spun a third and a fourth time and still did not migrate.

• 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: 8635756
• Report Number: 2618282-2019-00185
• Device Sequence Number: 2211277
• 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): 07/22/2019

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: 11/30/2019
• Device Catalogue Number: 365978
• Device Lot Number: 8262866
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 05/06/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/13/2019; 07/22/2019
• 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