MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problems Component Missing (2306); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was missing additive and foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer is experiencing lower cell count and "flakes" are observed in microscope.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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¿ mononuclear cell preparation tube there was missing additive and foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer is experiencing lower cell count and "flakes" are observed in microscope.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter or low yield was not observed.The photos appear to be taken through a microscope and show something irregularly shaped that is in the center of the field.It cannot be determined what this is or if it is or is not inherent to the process of the product.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to foreign matter or low yield were observed.The ifu (instructions for use) for this product does not specifically claim a yield of cells rather a percent recovery of the patient's whole blood cell count.The photos (microscopically performed) provided by this customer depict a substance with refractile nature.As this process is not part of bd's manufacturing or use guidelines, we cannot speculate on the nature of these refractile bodies.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 foreign matter or low yield.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was missing additive and foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer is experiencing lower cell count and "flakes" are observed in microscope.".

• Brand Name: BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE
• Type of Device: 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: 13317239
• MDR Text Key: 285642438
• Report Number: 1917413-2022-00008
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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: 1097633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1