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

Catalog 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	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? no, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study, unknown.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What was done to treat the shard penetration? band aide was medical or surgical intervention required? no.Was there any special diagnostic test performed? none.What is the status of the surgeon injury today? healed.Was it difficult to break the ampoule (was extra force needed to break the ampoule)? no.Was the ampoule crushed repeatedly? no.Can you identify the lot number of the product that was used? tpbdtx.Is the device available to be returned for evaluation? yes.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 an unknown procedure on (b)(6) 2024 and topical skin adhesive was used.The nurse using this went to crack this open and the glass came through the side of the tube and cut him.There was no patient consequences reported.There was no surgical delay.One device returning.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 evaluation: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the sample device was returned with the crushed ampoule and dried formulation inside the bulb.In addition, the package opened was returned along with the pen device.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.Visual inspection shows that all the components of the applicator are present and appropriately assembled.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A review of the batch manufacturing records was conducted, and no related 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.

• 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: 20230364
• Report Number: 2210968-2024-09777
• Device Sequence Number: 8667776
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: (01)10705031203525(17)251130(10)TPBDTX
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 11/30/2025
• Device Catalogue Number: DHVM12
• Device Lot Number: TPBDTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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