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

Model Number	261194
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 while using bd bbl¿ india ink reagent dropper the ink was injected under the skin of a patient.This is an off label use of this product.This material is a possible carcinogen and the patient received additional radiation treatment.The following information was provided by the initial reporter: "customer reporting injection with india ink into patient skin".
Additional Manufacturer Narrative
D6.Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 261194 (dropper india ink), lot number b02d125m, where it was requested if it was okay for the india ink to be injected subcutaneously." customer asking if product 261194 is acceptable for internal use." a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.A review of the device history record does not show any manufacturing issues.No photos or returns were available.Retention samples were satisfactory.Based on the investigation, no defect was observed.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.The product was used outside of product claims.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.Based on the evaluation of the investigation, the complaint was not confirmed.A definite root cause could not be determined.
Event or Problem Description
It was reported that while using bd bbl¿ india ink reagent dropper the ink was injected under the skin of a patient.This is an off label use of this product.This material is a possible carcinogen and the patient received additional radiation treatment.The following information was provided by the initial reporter: "customer reporting injection with india ink into patient skin.".

• Brand Name: BD BBL¿ INDIA INK 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12832422
• Report Number: 1119779-2021-01841
• Device Sequence Number: 11905042
• Product Code: JTS
• UDI-Device Identifier: 30382902611944
• UDI-Public: 30382902611944
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 05/17/2022

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: 02/28/2024
• Device Model Number: 261194
• Device Catalogue Number: 261194
• Device Lot Number: B02D125M
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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