MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ DMACA INDOLE REAGENT DROPPER; SEE H.10

Model Number 261187

Device Problem Leak/Splash (1354)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

D.3 common device name: discs, strips and reagents, microorganism differentiation.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

This report is for patient 2 out of 3.It was reported that while using the bd bbl¿ dmaca indole reagent dropper that there was staff that go cut with glass.The following information was provided by the initial reporter: customer reports that if there was any exposure to reagent in the techs' wounds, it was very little - pieces of glass were very small, but enough to cause pain and bleeding.Technicians did not go to a doctor - wounds were cleaned and band aids were sufficient.Injury occurred while testing patient samples.No patient impact - continued testing patients using other ampules.Customer received 2 boxes from fisher in february occurred to 2 techs on (b)(6) 2023, and 1 tech on (b)(6) 2023.Detailed hazard including any medical intervention: techs were cut by the glass ampule - bleeding fingers.Technician bloodborne pathogen risk.Fri (b)(6) 18:54:10 utc 2023 - patient fields updated: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details did erroneous results occur? no.Did a death occur? no.Did a serious injury occur? no.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes¿detailed hazard including any medical intervention: techs were cut by the glass ampule - bleeding fingers.Technician bloodborne pathogen risk.Customer reports that they had 2 occasions where a tech was cut by the glass ampule puncturing the side of the dropper.

Manufacturer Narrative

H.6.Investigation summary: this memo serves to summarize findings on your recent complaint 7532671 on product 261187 (dropper dmaca indole), lot number b01e322m, where it was observed that glass broke through the plastic bottle and caused a finger injury.Event description: "customer reports that they had 2 occasions where a tech was cut by the glass ampule puncturing the side of the dropper." 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 does not indicate any manufacturing issues.Sample analysis: a review of the provided photo did not indicate the noted defect.No glass was observed to be piercing the plastic.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.An inspection of the returns provided did not show any defect with the ampoule.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.No complaint trend exists on this issue with this product.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.

Event Description

It was reported that while using the bd bbl¿ dmaca indole reagent dropper that there was staff that go cut with glass.The following information was provided by the initial reporter: detailed hazard including any medical intervention: techs were cut by the glass ampule - bleeding fingers.Technician bloodborne pathogen risk fri (b)(6) 2023 - patient fields updated: hazard, injury or erroneous results? yes hazard, injury or erroneous results details did erroneous results occur? no did a death occur? no did a serious injury occur? no did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes if yes¿detailed hazard including any medical intervention: techs were cut by the glass ampule - bleeding fingers.Technician bloodborne pathogen risk customer reports that they had 2 occasions where a tech was cut by the glass ampule puncturing the side of the dropper.

• Brand Name: BD BBL¿ DMACA INDOLE REAGENT DROPPER
• Type of Device: SEE H.10
• 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: 16867805
• MDR Text Key: 314576961
• Report Number: 1119779-2023-00521
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902611876
• UDI-Public: 30382902611876
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 261187
• Device Catalogue Number: 261187
• Device Lot Number: B01E322M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Patient Outcome(s): Other