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

Catalog Number	DHVM12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2019 and topical skin adhesive was used.The physician crushed the ampule to release the liquid and it broke into many shards.The glass shards did not penetrate the tube.The fluid also went to the back of the device instead of toward the applicator.No one (patient or staff) was injured as a result.There were no adverse patient consequences.
Additional Manufacturer Narrative
(b)(4).Additional device evaluated by mfr investigation summary: it was reported that the device had performance/shard penetration.The analysis results found that the dhvm12 device was returned inside its package opened.Upon visual inspection, it was observed that the blister tray of the returned unit was opened containing a polymerized pen device.No other anomalies were observed related to shard penetration.No conclusion could be reached as to what may have caused the reported incident.

• Brand Name: DERMABOND MINI HV 0.36ML VIAL - 12EA
• Common Device Name: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9249734
• Report Number: 2210968-2019-89175
• Device Sequence Number: 11305646
• Product Code: MPN
• UDI-Device Identifier: 10705031203525
• UDI-Public: 10705031203525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 07/31/2020
• Device Catalogue Number: DHVM12
• Device Lot Number: MJH542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1