MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD CD103 FITC CE

Catalog Number 333155

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

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 while testing with bd cd103 fitc ce erroneous results were obtained.Results were not reported, however, there was a delay in obtaining results.The following information was provided by the initial reporter, translated from (b)(6) to english: following 2 inconsistent diagnoses, we have doubts about our cd103 marking.After comparisons with lot 9324896 (expired) and lot 1015695 (in stock; unopened), it appears that our vial of lot 0197826 is defective (no fluorescence obtained with beads, thus confirming our doubts.Could you please replace the defective vial and proceed with the appropriate controls on your side? 2 samples of patient have been implicated none false result have been communicated to the clinicians impact on patient : delay in the patient results.

Event Description

It was reported while testing with bd cd103 fitc ce erroneous results were obtained.Results were not reported, however, there was a delay in obtaining results.The following information was provided by the initial reporter, translated from french to english: following 2 inconsistent diagnoses, we have doubts about our cd103 marking.After comparisons with lot 9324896 (expired) and lot 1015695 (in stock; unopened), it appears that our vial of lot 0197826 is defective (no fluorescence obtained with beads, see attached document), thus confirming our doubts.Could you please replace the defective vial and proceed with the appropriate controls on your side? 2 samples of patient have been implicated: none false result have been communicated to the clinicians.Impact on patient : delay in the patient results.

Manufacturer Narrative

Mdr 3008352382-2021-00156 was filed in error.This product is not registered as a medical device in us and is not subject to mdr reporting.

• Brand Name: BD CD103 FITC CE
• Type of Device: NA
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11934768
• MDR Text Key: 280692887
• Report Number: 3008352382-2021-00156
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/30/2021

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: 07/31/2021
• Device Catalogue Number: 333155
• Device Lot Number: 0197826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1