MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367878
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	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode with the incident lot was 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 that bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes had "foreign matter" no report of injury or medical intervention.No report of blood exposure to mucous membrane.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS 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: 7591370
• Report Number: 1917413-2018-01968
• Device Sequence Number: 11237220
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• 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): 05/17/2018

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: 12/31/2016
• Device Catalogue Number: 367878
• Device Lot Number: 5175953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2016
• Initial Report FDA Received Date: 06/12/2018
• 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