MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ LACTOPHENOL COTTON BLUE STAIN DROPPER; STAINS, MICROBIOLOGIC

Model Number	261188
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bbl¿ lactophenol cotton blue stain dropper stick injury occurred in left index finger.Wound came in contact with lactophenol and was directly rinsed with water.No further medical intervention was needed.The following information was provided by the initial reporter: stick injury in the left index finger while opening the while, wound came in contact with lactophenol.
Additional Manufacturer Narrative
Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 261188 (dropper lactophenol cotton blue stain), lot number b02d216m, where it was observed that the broken glass punctured the plastic ampoule upon crushing it and injured the customer¿s finger.Event description: "stick injury in the left index finger while opening the while, wound came in contact with lactophenol." 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 any defect with the ampoule.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.An inspection of the photo provided did not show any defect with the ampoule.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.The product ifu does contain a caution statement, ¿caution: break ampule close to its center one time only.Do not manipulate the dropper any further as the plastic may puncture and injury may occur.¿ as no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.
Event or Problem Description
It was reported that bd bbl¿ lactophenol cotton blue stain dropper stick injury occurred in left index finger.Wound came in contact with lactophenol and was directly rinsed with water.No further medical intervention was needed.The following information was provided by the initial reporter: stick injury in the left index finger while opening the while, wound came in contact with lactophenol.

• Brand Name: BD BBL¿ LACTOPHENOL COTTON BLUE STAIN 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: 16587885
• Report Number: 1119779-2023-00321
• Device Sequence Number: 5729186
• Product Code: JTS
• UDI-Device Identifier: 30382902611883
• UDI-Public: 30382902611883
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 06/30/2024
• Device Model Number: 261188
• Device Catalogue Number: 261188
• Device Lot Number: B02D216M
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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