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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information: d4 lot: the actual device batch number associated with this event is not known.The customer reports the following possible batch numbers: lot: tbbctt: mfg date: 2/11/2023, exp date: 1/31/2025.Lot: tcbald mfg date: unk, exp date: unk.In addition, a review of the batch manufacturing records for the possible batch numbers are pending.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.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 an unknown date and topical skin adhesive was used.The resident physician experienced a small glass shard when cracking a ampoule, resulted in exposure to a patient¿s blood.The glass shard sticking outside the vial.' blood testing performed and pressure was held to finger to stop bleeding.Current condition of surgeon is healed.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4, d9, h4: the actual device batch number associated with this event is not known.The customer reports the following possible batch numbers: lot: tbbctt: mfg date: (b)(6) 2023, exp date: (b)(6) 2025 lot: tcbald mfg date: (b)(6) 2023, exp date: (b)(6) 2025 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 evaluation: the products were returned for evaluation.Sample a /lot: tcbald visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that two , lot tcbald devices were returned.One device was noted with the 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.Visual inspection shows that all the components of the applicator are present and appropriately assembled.Sample b / lot: unk in the other device, no crushed or piercing through was noted.The manufacturing records could not be reviewed as the batch/lot number is unknown.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Sample c / lot: tbbctt visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one, lot tbbctt, device was returned inside their package unopened.Upon visual inspection, no crushed or piercing through was noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without any visual or cosmetic defect.Although no packaging defect was identified, there may have been other circumstances or issues that occurred that could not be replicated during the laboratory analysis.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: 17391000
• Report Number: 2210968-2023-05379
• Device Sequence Number: 18378277
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: 10705031203525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 01/31/2025
• Device Catalogue Number: DHVM12
• Device Lot Number: TBBCTT
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2023
• 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