MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFR03

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: na (receiving inspection).Detailed description of event: this is a complaint from [name].The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: october 17, 2018.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.We found a new defect.We would like you to investigate the cause of this issue and would like you to have corrective action for following defects.(1) insufficient heat seal (foreign object in the heat seal).Patient status: na.Type of intervention: na.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that there was particulate matter in the seal.Testing was performed on the event unit, which determined that the sterile barrier had been compromised.Based on the condition of the returned unit, it is likely that the reported event happened during the packaging process.It is likely that the particulate matter got stuck on the chains of form fill and seal (ffs) machine and was incorporated into the pouch seal.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure being performed: na (receiving inspection).Detailed description of event: this is a complaint from [name].The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: october 17, 2018.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.I) we found a new defect.We would like you to investigate the cause of this issue and would like you to have corrective action for following defects ¿(1) insufficient heat seal (foreign object in the heat seal).Patient status: na.Type of intervention: na.

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9803080
• MDR Text Key: 182564638
• Report Number: 2027111-2020-00409
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)210830(30)01(10)1334885
• Combination Product (y/n): N
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/21/2021
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1334885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1