MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CALCOFLUOR WHITE REAGENT DROPPER; STAINS, MICROBIOLOGIC

Model Number	261195
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd bbl¿ calcofluor white reagent dropper pierced through the vial and cut a lab tech while he had soiled gloves on.The following information was provided by the initial reporter: calcofluor stain ampule crystal pierced through the vial and cut a lab tech while he had soiled gloves on.No exposure to blood was reported.They do not believe so as the scientist had just changed his gloves.
Additional 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.
Additional Manufacturer Narrative
H.6.Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 261195 (dropper calcofluor white), lot number b006e094m, where it was observed that glass broke through the plastic bottle and caused a finger injury.Event description: " calcofluor stain ampule crystal pierced through the vial and cut a lab tech while he had soiled gloves on." 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: no photos or returns were available.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 instruction for use (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.H3 other text : see h.10.
Event or Problem Description
It was reported that bd bbl¿ calcofluor white reagent dropper pierced through the vial and cut a lab tech while he had soiled gloves on.The following information was provided by the initial reporter: calcofluor stain ampule crystal pierced through the vial and cut a lab tech while he had soiled gloves on.No exposure to blood was reported.They do not believe so as the scientist had just changed his gloves.

• Brand Name: BD BBL¿ CALCOFLUOR WHITE REAGENT DROPPER
• Common Device Name: STAINS, MICROBIOLOGIC
• 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: 16864662
• Report Number: 1119779-2023-00515
• Device Sequence Number: 14822291
• Product Code: JTS
• UDI-Device Identifier: 30382902611951
• UDI-Public: 30382902611951
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 261195
• Device Catalogue Number: 261195
• Device Lot Number: B06E094M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown