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

Catalog Number	367961
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported with the use of the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes there was an issue with sporadic false elevated troponin results on 7 patients resulting in redraws.
Additional Manufacturer Narrative
The following field has been updated due to corrected information: unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported with the use of the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes there was an issue with sporadic false elevated troponin results on 7 patients resulting in redraws.
Event or Problem Description
It was reported with the use of the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes there was an issue with sporadic false elevated troponin results on 7 patients resulting in redraws.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd has provided troubleshooting related to the issue.Bd had made multiple attempts to reach the customer in order to gather more information on the lot number; however, bd had not received a response from the customer.A good faith effort has been made and this complaint will be closed without further investigation at this time.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample, photo, or lot number available for evaluation, a root cause could not be determined.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.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 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: 8271879
• Report Number: 1917413-2019-00112
• Device Sequence Number: 1557400
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2019

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 Catalogue Number: 367961
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019; 01/04/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/12/2019; 03/22/2019
• 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