MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366664
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5175911.Medical device expiration date: 11/30/2016.Device manufacture date: 06/24/2015.Bd received samples from the customer facility for investigation.The samples were not evaluated due to this being a previously investigated complaint.A review of the manufacturing records was completed for the incident lot and no issues were identified.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint.
Event or Problem Description
It was reported that bd vacutainer® lithium heparin (lh) 37 usp units blood collection tubes were experiencing low draws.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 37 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: 7579796
• Report Number: 1917413-2018-01992
• Device Sequence Number: 19214818
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: 04/30/2016
• Device Catalogue Number: 366664
• Device Lot Number: 4342770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2016
• Initial Report FDA Received Date: 06/07/2018
• 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