MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the expiration date on the blister pack of the topical skin adhesvie package is printed with an expiration date of 8/31/2012, whereas the expiration date on the outside of the box is 2019. There was no patient involvement.

Manufacturer Narrative

Product complaint # (b)(4). Date sent to fda: (b)(4) 2018. The actual sample was received for evaluation. Evaluation of the received sample disclosed that the tyvek label showed an expiration date of (b)(4) 2012, which is incorrect. Per device history records review, the correct expiration date for subject product code (clr222us) and batch ((b)(4)) combination is (b)(4) 2019. This is considered as incorrect and/or missing labeling condition.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7222717
• MDR Text Key: 98520511
• Report Number: 2210968-2018-70486
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/16/2019
• Device Catalogue Number: CLR222US
• Device Lot Number: LKH207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial