MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH FICOLL; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 06/14/2021

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® cpt¿ nh: ~130 iu ficoll¿: 2.0ml, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "it concerns the article 8ml cpt nahep tubes with ref 362780.We have noticed that these tubes cannot be filled optimally with this batch with lot number: 0311203.".

Event Description

It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "it concerns the article 8ml cpt nahep tubes with 362780.We have noticed that these tubes cannot be filled optimally with this batch with lot number: 0311203.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for underfill with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and draw testing and no issues were observed relating to underfill as all samples met specifications.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.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER CPT NH FICOLL
• 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: 12139349
• MDR Text Key: 260760417
• Report Number: 1917413-2021-00598
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0311203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1