MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The following information was requested and no response has been received.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.How the case was completed? were there any adverse patient consequences? is the device available for return to evaluate?.

Event Description

It was reported a patient underwent a total hip procedure on (b)(6) 2020 and surgical sealant was used.During surgery, it was noted the product had weird substance inside packaging that resembled blood.No patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4) date sent to the fda: 07/29/2020 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device batch pmr768, and no non-conformances were identified.Additional information was requested and the following was obtained: the case was successfully completed with no delay or adverse effects.The weird substance was noted upon opening the prineo package before dumping on sterile field.Another prineo was pulled and opened.The product in question was thrown away at time of the event.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.7yju.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 8/12/2020.H3 evaluation: a photo was received for analysis.No product was returned to evaluate.Upon visual inspection of the picture, a foreign matter was noted to be inside of the mesh package.However, no conclusion could be reached as to the origin of the foreign matter as the device was not returned for analysis.The photo does not provide enough evidence to determine root cause.A manufacturing record evaluation was performed for the finished device batch pmr768, clr222us15 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10242062
• MDR Text Key: 198108705
• Report Number: 2210968-2020-05105
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Device Lot Number: PMR768
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 08/04/2020
• Supplement Dates FDA Received: 07/29/2020; 08/12/2020
• Patient Sequence Number: 1