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

Model Number	CFR03
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9803080
• Report Number: 2027111-2020-00409
• Device Sequence Number: 19583932
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)210830(30)01(10)1334885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1