MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q20, 5X100 KII BALLOON BLUNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number C0Q20

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

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Name of procedure being performed: ni.Detailed description of event: "i received 1 c0q20, that has a small hole in the packaging." additional information received via email on 04jun2021 from [name]: "the hole was noticed in the or when they were pulling it for a procedure.The product is available for return." photos have been provided.Type of intervention: ni.Patient status: na: no patient's involvement.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of a hole in the packaging could not be confirmed.A scratch, which did not compromise the sterile barrier, was noted in the tyvek side.Based on the condition of the returned unit, the scratch likely occurred while the product was being handled.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

Event Description

Name of procedure being performed: na.Detailed description of event: "i received 1 c0q20, that has a small hole in the packaging." additional information received via email on 04jun2021 from [name]: "the hole was noticed in the or when they were pulling it for a procedure.The product is available for return." photos have been provided.Type of intervention: na.Patient status: na - no patient's involvement.

• Brand Name: C0Q20, 5X100 KII BALLOON BLUNT TIP 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: 12041319
• MDR Text Key: 261512460
• Report Number: 2027111-2021-00537
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915124878
• UDI-Public: (01)00607915124878(17)240204(30)01(10)1407306
• Combination Product (y/n): N
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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: 02/04/2024
• Device Model Number: C0Q20
• Device Catalogue Number: 101221501
• Device Lot Number: 1407306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1