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

Catalog Number 362780

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had erroneous results.No serious injury or medical intervention.

Event Description

It was reported that bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had erroneous results.No serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were not evaluated for the customer's indicated failure mode for low yield with the incident lot as instructions for use(ifu) for this tube does not specifically claim a yield of cells rather a percent recovery of the patient's whole blood cell count.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: bd received samples from the customer facility for investigation.The samples were not evaluated for the customer's indicated failure mode for low yield with the incident lot as instructions for use(ifu) for this tube does not specifically claim a yield of cells rather a percent recovery of the patient's whole blood cell count.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

Event Description

It was reported that bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had erroneous results.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7594380
• MDR Text Key: 111172170
• Report Number: 1917413-2018-01724
• 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,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 362780
• Device Lot Number: 7272779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 03/14/2018; 03/14/2018
• Supplement Dates FDA Received: 08/02/2018; 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other