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

Model Number 261193

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

It was reported that upon opening 8 packs tubes from a different chemical box were mixed with product bd bbl¿ voges-proskauer b reagent dropper.No injuries were reported.The following information was provided by the initial reporter: customer reports that when the end user opened the pack, there was a mixture of 261193 and tubes of another chemical within the box.

Manufacturer Narrative

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

Manufacturer Narrative

H.6 investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 261193 (dropper voges-proskauer b), lot number unknown, where it was observed that there was a box of mixed dropper bottles.Event description: " customer reports that when the end user opened the pack, there was a mixture of 261193 and tubes of another chemical within the box." 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 device history record could not be performed as a lot number was not provided.Sample analysis: the photos that were provided did not show any defects.The retention samples could not be inspected as a lot number was not provided.Evaluations results: based on the investigation, no defect was observed.No complaint trend exists on this issue with this product.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.However, bd will continue to monitor for trending.

Event Description

It was reported that upon opening 8 packs tubes from a different chemical box were mixed with product bd bbl¿ voges-proskauer b reagent dropper.No injuries were reported.The following information was provided by the initial reporter: customer reports that when the end user opened the pack, there was a mixture of 261193 and tubes of another chemical within the box.

• Brand Name: BD BBL¿ VOGES-PROSKAUER B 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16612373
• MDR Text Key: 312413145
• Report Number: 1119779-2023-00328
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902611937
• UDI-Public: 30382902611937
• 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: 09/19/2023

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 Model Number: 261193
• Device Catalogue Number: 261193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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