MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
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	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
2 of 2.It was reported while using bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg, sample with extremely high alcohol concentration.The following information was provided by the initial reporter: customer alleging a quality issue that has arisen with some recently manufactured bd vials, potentially, and wondering if you could share what you have learned about their manufacturing concerns.Two samples come back with extremely high, not likely to be seen in a living person, alcohol concentrations.Customer inquiring if they had a qc issue or changed volatiles that they were using in their process that could be off-gassing.The 2 erroneous alcohol results were drawn by the same phlebotomist on 2 separate individuals 2 weeks apart.Both had the same extremely high blood alcohol result of 1.0%, which she stated in her email, "not likely to be seen in a living person." the second individual had breath test result of 0.20.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 15 product samples, which were returned by the customer (the ¿customer¿s product samples¿).The customer¿s product samples were evaluated along with product retention samples of the same lots from bd inventory (¿product retention samples¿) and samples from bd inventory from a different lot (¿control samples¿).As described below, bd tested the customer¿s product samples, control samples, and product retention samples.No issues relating to the reported erroneous results, i.E., unexpected high alcohol concentrations, were observed.In response to the customer¿s report, bd conducted the following: testing of product retention samples: bd¿s product retention samples (of the same lot) were tested by conducting visual inspections and draw testing.Testing of customer¿s product samples: the customer¿s product samples (along with controls from a different lot) were tested via tube headspace gc-ms for ethanol content.Device history record (dhr) review: based on a review of the dhr for the incident lot, all product specifications and requirements for lot release were met.A complaint history was performed, and this was the only complaint found on this batch number for the reported issue.Complaint history: a complaint history review was performed, and this was the only complaint found on this batch number for the reported issue.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 2022-07-20.
Event or Problem Description
2 of 2.It was reported while using bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg, sample with extremely high alcohol concentration.The following information was provided by the initial reporter: customer alleging a quality issue that has arisen with some recently manufactured bd vials, potentially, and wondering if you could share what you have learned about their manufacturing concerns.Two samples come back with extremely high, not likely to be seen in a living person, alcohol concentrations.Customer inquiring if they had a qc issue or changed volatiles that they were using in their process that could be off-gassing.The 2 erroneous alcohol results were drawn by the same phlebotomist on 2 separate individuals 2 weeks apart.Both had the same extremely high blood alcohol result of 1.0%, which she stated in her email, "not likely to be seen in a living person." the second individual had breath test result of 0.20.Tions.

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE
• Common Device Name: 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: 15070772
• Report Number: 1917413-2022-00426
• Device Sequence Number: 14796864
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: 1259228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown