MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 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 Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for erroneous results with the incident lot was not observed as all product specifications were met.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd does not recommend pst tubes be used for blood gases.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for erroneous results with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd vacutainer® pst¿ gel and lithium heparin (lh) 126 units blood collection tubes had erroneous results.No serious injury or medical intervention.
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Bd does not recommend pst tubes be used for blood gases.Investigation conclusion: the customer¿s indicated failure mode for erroneous results with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.
Event or Problem Description
It was reported that bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes had erroneous results.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 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: 7580917
• Report Number: 1917413-2018-01580
• Device Sequence Number: 19406172
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/14/2019

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: 04/30/2018
• Device Catalogue Number: 367964
• Device Lot Number: 7100542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 03/15/2019
• 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