MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED 0.7ML - 12EA; ADHESIVE, TOPICAL SKIN

Catalog Number ANX12

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If further details are received at a later date a supplemental medwatch will be sent.H3 evaluation: the product sample was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was returned outside its packaging and only the tyvek was returned with the instrument.Upon visual inspection, a unknown foreign matter was noted to be between the ampoule and pen.As part of quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on how the foreign matter was introduced inside the sterile package, it is possible that the foreign matter adhered to the device during the packaging process due to static.The reported complaint was observed.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.

Event Description

It was reported a patient underwent an unknown breast surgery on (b)(6) 2023 and topical skin adhesive was used.Before opening the package, there was a brown string-like substance in the content fluid so the product was not used.There were no adverse consequences to the patient.

• Brand Name: DERMABOND ADVANCED 0.7ML - 12EA
• Type of Device: 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18123079
• MDR Text Key: 328012849
• Report Number: 2210968-2023-08774
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ANX12
• Device Lot Number: TDBBPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1