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 04/04/2023

Event Type  Injury  

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

It was reported that while using the bd bbl¿ dmaca indole reagent dropper that a tech was cut by the glass ampule puncturing the side of the dropper.The following information was provided by the initial reporter: quantity received and quantity affected: 1 ampule affected, 2 boxes received was this issue involving patient or nonpatient samples? patient.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 another occasion where a tech was cut by the glass ampule puncturing the side of the dropper.

Event Description

It was reported that while using the bd bbl¿ dmaca indole reagent dropper that a tech was cut by the glass ampule puncturing the side of the dropper.The following information was provided by the initial reporter: quantity received and quantity affected: 1 ampule affected, 2 boxes received.Was this issue involving patient or nonpatient samples? patient.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 another occasion where a tech was cut by the glass ampule puncturing the side of the dropper.

Manufacturer Narrative

H6: investiation summary: this memo serves to summarize findings on your recent complaint (b)(4) 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 another occasion 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: an inspection of the photo did not indicate the noted defect.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.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.It is recommended to follow the testing procedure as defined in the ifu and squeeze the ampoule only once.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.

• 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: 16878817
• MDR Text Key: 314715389
• Report Number: 1119779-2023-00529
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Patient Outcome(s): Other