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

Model Number 367960

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube there was erroneous results.The following information was provided by the initial reporter.It was reported that there was a patient impacted.The lot number on the green top tubes is 2018932 exp.01/31/2023." 2022-04-07 additional information received: 5 patients had their blood collected in pst tubes cat #367960 lot #2018932, and the analysis showed elevated troponin and decreased sodium.One of the patients got hospitalized because of this result but was later cleared.Blood from these patients was also collected in lavender (edta) tubes and green (heparin) tubes, and all the results were normal, no issues.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure mode (erroneous results) because the defect was not evident in the testing of the complaint lot samples.Replicates of customer, retain and control samples were acceptable in terms of both precision and accuracy.All visual observations of customer, retain and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.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.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.Factors that may contribute to erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.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 heparinn (lh) blood collection tube there was erroneous results.The event occurred 5 times.The following information was provided by the initial reporter.It was reported that there was a patient impacted.The lot number on the green top tubes is 2018932 exp.01/31/2023." 2022-04-07, additional information received: 5 patients had their blood collected in pst tubes cat#: 367960, lot#: 2018932, and the analysis showed elevated troponin and decreased sodium.One of the patients got hospitalized because of this result but was later cleared.Blood from these patients was also collected in lavender (edta) tubes and green (heparin) tubes, and all the results were normal, no issues.

• 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: 14147797
• MDR Text Key: 289767818
• Report Number: 1917413-2022-00211
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679602
• UDI-Public: 50382903679602
• 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
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 367960
• Device Catalogue Number: 367960
• Device Lot Number: 2018932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other