MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366065
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
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 with the use of the bd seditainer¿ 0.105m 1.25ml buffered sodium citrate blood collection tubes there was an issue with overfill.There was no report of injury or medical intervention.
Event or Problem Description
It was reported with the use of the bd seditainer¿ 0.105m 1.25ml buffered sodium citrate blood collection tubes there was an issue with overfill.There was no report of injury or medical intervention.
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 overfill with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to overfill 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.Additionally, bd technical services provided troubleshooting and education material to the customer.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for overfill 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.

• Brand Name: BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 8059756
• Report Number: 9617032-2018-03035
• Device Sequence Number: 18901239
• Product Code: JKA
• UDI-Device Identifier: 50382903660655
• UDI-Public: 50382903660655
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K953994
• 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): 11/27/2018

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: 01/31/2019
• Device Catalogue Number: 366065
• Device Lot Number: 8030733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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