MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP EXTENDED TIP APPLICATOR 15CM BOX OF 5; SEALANT APPLICATORS

Catalog Number 205115

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The device was discarded by the customer.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number 3003418325-2020-00007.

Event Description

This is 2 of 2 reports.It was initially reported to integra on 08may2020 that the 205115 extended tip applicator has clogged during application of duraseal at two different times.They cut the very end of the tip off so they could complete the application of the duraseal.Patient contact was unknown.No patient injury reported.Additional information received on 12may2020 and 21may2020 indicating that the product was used during surgery and it happened twice during two different minimally invasive spine procedures.The date of incident occurred within (b)(6) 2020.There was a delay for at least five (5) minutes as the surgeon tried to fix the problem.There was no adverse consequence to the patient.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.The device was not returned for evaluation, as such the reported issue could not be confirmed or further evaluated.However, at the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.The investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.

• Brand Name: EXTENDED TIP APPLICATOR 15CM BOX OF 5
• Type of Device: SEALANT APPLICATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10280892
• MDR Text Key: 202568376
• Report Number: 3003418325-2020-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K091315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205115
• Device Lot Number: 2109091374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1