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

Catalog Number 367962

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device evaluated by mfr: 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 Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes, the device experienced erroneous results listed at 5.4 elevated potassium levels.The following information was provided by the initial reporter.The customer stated: patient a; on (b)(6) and the potassium level was 5.4 analyzer name and model # roche cobas 8000 ise four instruments.Repeats >5.1 repeat and a new draw.Good reproducibilty on repeat high potassiums noted.Customer is alleging erroneous potassium results with the lithium heparin tube.

Manufacturer Narrative

This correction report is being sent to correct the previously submitted report 1917413-2022-00783 date received by manufacturer is 09-nov-2022.

Event Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes, the device experienced erroneous results listed at 5.4 elevated potassium levels.The following information was provided by the initial reporter.The customer stated: patient a: on 9/14 and the potassium level was 5.4.Analyzer name and model # roche cobas 8000 ise four instruments.Repeats >5.1 repeat and a new draw.Good reproducibility on repeat high potassium's noted.Customer is alleging erroneous potassium results with the lithium heparin tube.

Manufacturer Narrative

H.6 investigation summary material #: 367962 lot/batch #: 1350381, unknown bd received 2 samples for investigation.100 retentions were inspected with no issues being identified.Clinical testing could not be conducted as the samples had already expired at the time of review.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.A complaint history was conducted and only this complaint has been received on this batch number and the reported defect.This complaint is unable to be confirmed for the indicated failure mode erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes, the device experienced erroneous results listed at 5.4 elevated potassium levels.The following information was provided by the initial reporter.The customer stated: patient a on 9/14 and the potassium level was 5.4 analyzer name and model # roche cobas 8000 ise four instruments.Repeats >5.1 repeat and a new draw.Good reproducibilty on repeat high potassiums noted.Customer is alleging erroneous potassium results with the lithium heparin tube.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15982891
• MDR Text Key: 306911817
• Report Number: 1917413-2022-00783
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679626
• UDI-Public: 00382903679621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367962
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/17/2023; 03/21/2023
• Supplement Dates FDA Received: 01/18/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male