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	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient undewent an unknown procedure on an unknown date in 2023 and topical skin adhesive was used.Dr cracked the vial of the adhesive and unknowingly, a shard of the glass ampule pierced the plastic housing of it.Upon application of the md's finger was scratched by this glass shard, which pierced through his gloves and left a superficial scratch on his finger.There was no treatment or intervention performed.Dr status is fine.There were no patient consequences reported.Unknown if the device is available for return.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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.Please clarify, how was the dermabond mini defective? please elaborate on the quality issue experienced.Md cracked the vial of the dermabond and unknowingly, a shard of the glass ampule pierced the plastic housing of the dermabond.Upon application of the md's finger was scratched by this glass shard, which pierced through his gloves and left a superficial scratch on his finger.What is the product code? dhvm12.What is the lot number? tabhka.Are there pictures of the damaged device available? yes.Is the damaged device available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? yes.What was done to treat the shard penetration? no.Was medical or surgical intervention required? no.Was there any special diagnostic test performed? no.What is the status of the surgeon injury today? unaffected.Was it difficult to break the ampoule (was extra force needed to break the ampoule)? no.Was the ampoule crushed repeatedly? no.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information has been requested and received.What was done to treat the shard penetration? surgeon cleaned hand.Was medical or surgical intervention required? no.Was there any special diagnostic test performed? no.What is the status of the surgeon injury today? unknown.Was it difficult to break the ampoule (was extra force needed to break the ampoule)? unknown.Was the ampoule crushed repeatedly? unknown.Pain to hand, improving.No breaks to skin.No it was standard break to ampule.No, not crushed repeatedly.No medical intervention required, no tests.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 device was returned 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.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photos shown one product 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.Based on the review, the event described shard penetration confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• 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: 16790598
• Report Number: 2210968-2023-02927
• Device Sequence Number: 5523069
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: 10705031203525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/19/2023

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: 12/31/2024
• Device Model Number: DHVM12
• Device Catalogue Number: DHVM12
• Device Lot Number: TABHKA
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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