MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA ISOLATE SUSPENSION CUVETTE ARRAY 120 PER BOX; DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

Catalog Number 246100

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 that 5 bd kiestra isolate suspension cuvette array 120 per box kits were received without labels.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese: according to the customer's report, there were products without the barcode label.

Event Description

It was reported that 5 bd kiestra isolate suspension cuvette array 120 per box kits were received without labels.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese: according to the customer's report, there were products without the barcode label.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation of a complaint involving bd kiestra isolate suspension cuvettes.According to information provided, a barcode was missing.No other issues were reported.During investigation, the provided pictures were assessed, which showed that there was no barcode.Following this action, no further issues were encountered.New cuvettes were provided to the customer.Based on investigation, this case has been assessed as confirmed for a bd quality issue.Review found no new trends, risks, or hazards were identified because of this complaint.A design history record (dhr) review is not required for this complaint.The complaint was evaluated via other elements of the investigation.Bd quality will continue to closely monitor for trends associated with this issue.

• Brand Name: BD KIESTRA ISOLATE SUSPENSION CUVETTE ARRAY 120 PER BOX
• Type of Device: DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17313007
• MDR Text Key: 319486280
• Report Number: 1119779-2023-00771
• Device Sequence Number: 1
• Product Code: LIB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 09/05/2023

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: 12/28/2023
• Device Catalogue Number: 246100
• Device Lot Number: LM242722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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