MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367964
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes initial reporter state: address information was not able to be obtained, however, (b)(6)was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported while using bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes erroneous results were obtained.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the lot yields bad results.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was able to confirm the reported condition in the clinical testing conducted.The customer¿s reported concern was replicated in a single retain sample.In addition, retention samples were tested for additive abnormalities.All testing was within specification with no abnormalities identified.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 has been confirmed for erroneous results based on the clinical testing performed.A root cause could not be determined.
Event or Problem Description
It was reported while using bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes erroneous results were obtained.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the lot yields bad results.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11233522
• Report Number: 1917413-2021-00047
• Device Sequence Number: 3805268
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 04/30/2021
• Device Model Number: 367964
• Device Catalogue Number: 367964
• Device Lot Number: 0100300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1