MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PST¿ GEL/LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367964
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."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 #: 6216626.Medical device expiration date: 08/31/2017.Device manufacture date: 08/03/2016." bd had received contaminated samples which could not be used for evaluation.Bd did not receive photos from the customer facility for evaluation; therefore, the investigation was limited.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® pst¿ gel and lithium heparin (lh) 126 units blood collection tubes had poor gel migration.

• Brand Name: BD VACUTAINER® PST¿ GEL/LITHIUM HEPARINN (LH) 126 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: 7485014
• Report Number: 1917413-2018-01177
• Device Sequence Number: 1718680
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 04/25/2018

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: 02/28/2018
• Device Catalogue Number: 367964
• Device Lot Number: 7033711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 05/03/2018
• 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