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

Catalog Number	369741
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for the additional lot number is as follows: medical device lot #: 7100570.Medical device expiration date: 10/31/2018.Returned to manufacturer on: unknown.Device manufacture date: 04/10/2017." bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported that the bd vacutainer® esr blood collection tubes under filled.

• Brand Name: BD VACUTAINER® ESR BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7496882
• Report Number: 1917413-2018-02343
• Device Sequence Number: 1718586
• Product Code: JKA
• UDI-Device Identifier: 50382903697415
• UDI-Public: 50382903697415
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945952
• 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
• Report Date (Section B): 05/04/2018

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: 09/30/2018
• Device Catalogue Number: 369741
• Device Lot Number: 7067566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 05/08/2018
• 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