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

Model Number	C0Q20
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned for evaluation to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12041319
• Report Number: 2027111-2021-00537
• Device Sequence Number: 3979952
• Product Code: GCJ
• UDI-Device Identifier: 00607915124878
• UDI-Public: (01)00607915124878(17)240204(30)01(10)1407306
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1