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	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that bd vacutainer® lithium heparin (lh) 37 usp units blood collection tubes had "erroneous results." no serious injury or medical intervention.
Additional Manufacturer Narrative
Additional information: bd is issuing a voluntary medical device correction for bd vacutainer® plastic lithium heparin tubes.False elevation of carboxyhemoglobin (cohb) results have been reported when analyzing venous blood samples collected with bd vacutainer® plastic lithium heparin tubes with the il gem 4000 instrument.Please reference bd recall #: pas-18-1175-fa.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes had "erroneous results." no serious injury or medical intervention.

• 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: 7594670
• Report Number: 1917413-2018-01851
• Device Sequence Number: 1624157
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 10/31/2016
• Device Catalogue Number: 366664
• Device Lot Number: 5154680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PAS-18-1175-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other