MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/23/2021

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 there was discolored/abnormal additive form.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: "the color of the gel is significantly darker than with previous tubes.The customer opened a new package and in comparison to previous lots the color of the gel in the tubes is significantly darker.".

Event Description

It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was discolored/abnormal additive form.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: "the color of the gel is significantly darker than with previous tubes.The customer opened a new package and in comparison to previous lots the color of the gel in the tubes is significantly darker.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-24.H6: investigation summary: bd received four (4) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for gel color variation with the incident lot was not observed.The gel color appears within specification limits.Additionally, thirty-one (31) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to gel color variation 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.This complaint is unable to be confirmed for the indicated failure mode of gel color variation.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML
• 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: 12324789
• MDR Text Key: 266665071
• Report Number: 1917413-2021-00730
• 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: 09/16/2021

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
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 362780
• Device Lot Number: 1097630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1