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

Model Number 367921

Device Problem Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

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® sodium fluoride potassium oxalate (fx) blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "no label.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for missing label with the incident lot was observed.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 the indicated failure mode missing label.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "no label".

• Brand Name: BD VACUTAINER SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12240037
• MDR Text Key: 264522874
• Report Number: 1917413-2021-00674
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679213
• UDI-Public: 50382903679213
• Combination Product (y/n): N
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 367921
• Device Catalogue Number: 367921
• Device Lot Number: 1014132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1