MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CATALASE REAGENT DROPPER; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Catalog Number 261203

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ catalase reagent dropper dates of expiration on box and bottle do not match the coc.The following information was provided by the initial reporter: reported certificate of compliance and shipment detail document  with lot# b01f122m  dated  july 2024 but the box and droppers  has lot# b01f122m  dated june 2024.Spoke with cx and she verified for lot# b01f122m has date  july 2024.Would you send our customer a no charge replacement with a box that has  lot# b01f122m has dated  july 2024.

Manufacturer Narrative

H6.Investigation summary: complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the dhr did not reveal any manufacturing issues.Sample analysis: an inspection of the photo did the noted defect.An inspection of the retentions was satisfactory.The erp system that generated the certificate had the wrong expiration date.Evaluations results: based on the investigation, the defect was observed on the photo and erp system.The wrong data was entered into the erp system which caused the noted discrepancy.A complaint trend is not present.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.The expiration date was corrected in the erp system and the certificate corrected.A complaint trend on this issue is not present with this product.No further actions will be taken as this is an isolated incident.Bd will continue to monitor for trending.

Event Description

It was reported that bd bbl¿ catalase reagent dropper dates of expiration on box and bottle do not match the coc.The following information was provided by the initial reporter: reported certificate of compliance and shipment detail document  with lot# b01f122m  dated  (b)(6) 2024 but the box and droppers  has lot# b01f122m  dated (b)(6) 2024.Spoke with cx and she verified for lot# b01f122m has date (b)(6) 2024 would you send our customer a no charge replacement with a box that has  lot# b01f122m has dated  (b)(6) 2024.

• Brand Name: BD BBL¿ CATALASE REAGENT DROPPER
• Type of Device: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17466875
• MDR Text Key: 320486179
• Report Number: 1119779-2023-00838
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902612033
• UDI-Public: 30382902612033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 261203
• Device Lot Number: B01F122M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1