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	03/19/2021
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.
Event or Problem Description
It was reported that bd vacutainer® blood alcohol determinations sodium fluoride had discolored additive.The following information was provided by the initial reporter: "material no.367001, batch no.0345747.It was reported that the additive in the tubes is caked on the sides.Per email: hi, our edmonton warehouse received : 5cs of 367001 lot 0345747 on po 4512336235, 1cs of 367001 lot 0345747 on po 4512352818, 1cs of 367001 lot 0345747 on po 4512434764, 3cs of 367001 lot 0345747 on po 4512473616.They are guessing these are the salts they see on the side of the tubes and stuck to the caps.They have not seen powder caked on the sides of any of these bd tubes before.The seals are good.Please advise if they are in good conditions.Thank you.".
Additional Manufacturer Narrative
H6: investigation summary: no samples and 3 photos were returned by the customer in support of this complaint.Visual examination of photos was performed and did not reveal any additive abnormality.The product contains a powder additive and is shipped on its side, the powder will migrate up the tube wall during the shipment process.Bd was unable to duplicate or confirm the customer¿s indicated failure mode from the photos provided.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported that bd vacutainer® blood alcohol determinations sodium fluoride had discolored additive.The following information was provided by the initial reporter: "material no.367001, batch no.0345747.It was reported that the additive in the tubes is caked on the sides.Per email: hi, our edmonton warehouse received : ¿ 5cs of 367001 lot 0345747 on po 4512336235.¿ 1cs of 367001 lot 0345747 on po 4512352818.¿ 1cs of 367001 lot 0345747 on po 4512434764.¿ 3cs of 367001 lot 0345747 on po 4512473616.They are guessing these are the salts they see on the side of the tubes and stuck to the caps.They have not seen powder caked on the sides of any of these bd tubes before.The seals are good.

• 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
• MDR Report Key: 11637917
• Report Number: 1917413-2021-00282
• Device Sequence Number: 17068147
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 12/31/2022
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: 0345747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1