MAUDE Adverse Event Report: ETHICON INC. DERMABOND MINI HV 0.36ML VIAL - 12EA; ADHESIVE, TOPICAL SKIN

Model Number	DHVM12
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4).Additional information has been requested and the following was received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental will be sent.What was done to treat the shard penetration? was medical or surgical intervention required? was there any special diagnostic test performed? what is the status of the surgeon injury today? was it difficult to break the ampoule (was extra force needed to break the ampoule)? was the ampoule crushed repeatedly? can you identify the lot number of the product that was used? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? if yes, what is the device return status? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent a cabg procedure on (b)(6) 2022 and topical skin adhesive was used.During use,when mixing the product the ampule broke and a shard of glass pierced the assistant's glove.No injury was sustained to the user.No patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: d4, d9, h4.H3 evaluation: the device was returned for analysis.Upon visual inspection, it was observed a crushed ampoule and dried formulation inside the bulb.The filter is purple in color due to contact with the formulation.The sample reveals a piercing through which a glass shard protruded in the applicator bulb.Also, a piercing in the butyrate tube is observed.These piercings coincided in position.Visual inspection shows that all the components of the applicator are present and appropriately assembled.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device history review = > n/a.

• Brand Name: DERMABOND MINI HV 0.36ML VIAL - 12EA
• Common Device Name: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16109335
• Report Number: 2210968-2023-00125
• Device Sequence Number: 7654273
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: 10705031203525
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2024
• Device Model Number: DHVM12
• Device Catalogue Number: DHVM12
• Device Lot Number: SKBBTZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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
• Patient Sex: Unknown