MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD OVUM ASPIRATION NEEDLE SINGLE LUMEN; MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES

Catalog Number K-OPS-1735-R-B-90

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The needles are causing extra bleeding.It was reported that this problem occurred multiple times in the week prior to (b)(6) 2017.The exact quantity was not confirmed.

Manufacturer Narrative

The complaint device was not returned for evaluation.After three requests for additional information, no further information has been received.The lot number of the device was not supplied.Therefore, review of the device history record cannot be conducted.There are multiple processes and checks during manufacturing that ensure that the echotipping is according to specifications."the diameters of the dimples of the needle are measured using image pro plus software and a microscope." "check all dimensions of the dimpling on the automated needle measurement computer".There are multiple processes and checks during manufacturing that ensure that the needle tip is within specification to meet sharpness requirements.Throughout manufacturing, the tip is covered with a tip protector or needle protector and all products are also packed and shipped with a needle protector."remove and discard needle tip protector (if applicable).Check each tip individually using the microscope to ensure that the tip has not been damaged"."product inspection sample size is 100%"."use microscope with 15x magnification".There are multiple processes and checks during manufacturing that ensure that the cannula is not bent or damaged."visually check the cannula surface for damage or marks.(e.G.Tape residue) then place into a tray for a final count"."inspect the packaging to check product has been packed neatly and that the product seal is intact." this check applies to 100% of products.Ifu set with the device states: "the sterile needle should be inspected for tip sharpness and kinking of any supplied tubing." based on the information present, a definitive root cause could not be determined for the complaint it is possible that the following factors contributed to the complaint: incorrect set-up of the needle in the ultrasound probe causing misalignment of the needle tip from the intended puncture tip.Incorrect set-up of the ultrasound machine.Operator error in technique using the ultrasound machine to visualise the procedure.

Event Description

The needles are causing extra bleeding.It was reported that this problem occurred multiple times in the week prior to (b)(6) 2017.The exact quantity was not confirmed.

• Brand Name: OVUM ASPIRATION NEEDLE SINGLE LUMEN
• Type of Device: MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: nicolas bidaud ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113 ; 738411188
• MDR Report Key: 6745862
• MDR Text Key: 81432758
• Report Number: 9680654-2017-00019
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OPS-1735-R-B-90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• 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