MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	362725
Medical Device Problem Codes	Incorrect Measurement (1383); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Result: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode with the incident lot was observed.Additionally, customer samples and retention samples were selected for evaluation, and the customer's indicated failure mode was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.
Event or Problem Description
It was reported the bd vacutainer® est z (no additive) plus blood collection tubes were coring, no report of medical interventions or serious injury.
Additional Manufacturer Narrative
Corrected to exempt.

• Brand Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7483211
• Report Number: 9617032-2018-00836
• Device Sequence Number: 2053480
• Product Code: JKA
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: 04/30/2018
• Device Catalogue Number: 362725
• Device Lot Number: 6299906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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