MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER SST; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365967
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd microtainer® sst¿, the device experienced erroneous results.The following information was provided by the initial reporter.The customer stated: during a clinical trial conducted at the babson diagnostics site during the week of (b)(6) 2021, the customer shared with bd on (b)(6) 2021, instances of elevated levels of hemolysis, resulting in falsely high potassium results, when using bd microtainer® sst tubes as a comparator device.The customer attributed the elevated levels of hemolysis to a pre-analytical variable.Subject id (b)(6).Sample type: venous t07 potassium: 4.91.Sample type: microtainer t04 potassium: 6.
Event or Problem Description
It was reported when using the bd microtainer® sst¿, the device experienced erroneous results.The following information was provided by the initial reporter.The customer stated: during a clinical trial conducted at the babson diagnostics site during the week of (b)(6) 2021, the customer shared with bd on (b)(6) 2021, instances of elevated levels of hemolysis, resulting in falsely high potassium results, when using bd microtainer® sst tubes as a comparator device.The customer attributed the elevated levels of hemolysis to a pre-analytical variable.Subject id 9a1-001: sample type: venous t07 potassium: 4.91.Sample type: microtainer t04 potassium: 6.
Additional Manufacturer Narrative
Investigation: bd had not received samples or photos for investigation.To further investigate, retention samples from bd inventory were evaluated by visual examination for barrier gel characteristics and presence of additive, and upon completion, no issues were observed that would lead to hemolysis or erroneous results as all samples met specifications.The customer has acknowledged that phlebotomy technique was the cause of their reported issue.Bd recommends appropriate technique reviews to mitigate hemolysis occurrences.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.On jun.29, 2021, a complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Based on the investigation performed, this complaint is unable to be confirmed for the indicated failure mode of hemolysis and erroneous results.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD MICROTAINER SST
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 12140033
• Report Number: 2618282-2021-00040
• Device Sequence Number: 3704611
• Product Code: JKA
• UDI-Device Identifier: 50382903659673
• UDI-Public: 50382903659673
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 365967
• Device Catalogue Number: 365967
• Device Lot Number: 1055749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1