MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368045
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
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 with the use of the bd vacutainer® serum blood collection tubes there was an issue with foreign matter.There was no report of injury or medical intervention.
Event or Problem Description
It was reported with the use of the bd vacutainer serum blood collection tubes there was an issue with foreign matter.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7876891
• Report Number: 1024879-2018-01191
• Device Sequence Number: 11389781
• Product Code: JKA
• UDI-Device Identifier: 00382903680450
• UDI-Public: 00382903680450
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• 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): 10/25/2018

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: 03/31/2019
• Device Catalogue Number: 368045
• Device Lot Number: 7082520
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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