MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PST¿ GEL & LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367961
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.This complaint is confirmed to be within the scope of a known issue.Quality has previously reviewed, evaluated and investigated this failure mode.No further action is required at this time.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint; reference (b)(4).
Event or Problem Description
It was reported that the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes were not filling to acceptable levels.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® PST¿ GEL & LITHIUM HEPARINN (LH) 65 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: 7593743
• Report Number: 1917413-2018-00805
• Device Sequence Number: 19143033
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/23/2018

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: 11/30/2017
• Device Catalogue Number: 367961
• Device Lot Number: 6313718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• 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