MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number C0R50

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: na (incoming inspection).Detailed description of event: [distributor] incoming inspection po#: 23065.This is a complaint from [distributor] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: on (b)(6) 2022.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 the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Hairlike object in pouch - c0r50 lot#: 1464958 (1 ea.).Type of intervention: na (incoming inspection).Patient status: na (no patient involvement).

Event Description

Name of procedure being performed: na (incoming inspection).Detailed description of event: [distributor] incoming inspection po (b)(4).This is a complaint from [distributor] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: november 28,2022 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 the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.- hairlike object in pouch - c0r50 lot #1464958 (1 ea.).Type of intervention: na (incoming inspection).Patient status: na (no patient involvement).

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16131205
• MDR Text Key: 308750882
• Report Number: 2027111-2023-00313
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)251018(30)01(10)1464958
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: Other
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1464958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1