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-OSN-1735-B-90-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Aspiration/Inhalation (1725); Unspecified Infection (1930)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) granted on the (b)(6) 2018: (b)(4).

Event Description

The patient developed an infection (bilateral tubal ovarian abscess) after having an ovum aspiration (cyst aspiration) performed.

Manufacturer Narrative

Pma/510(k) granted on the 12 january 2018: k171625.The device was not returned for evaluation.A lot number was not provided for this complaint, therefore a review of the device history record could not be performed.Further information was requested from the healthcare facility to determine how the device may have contributed to the event.Three attempts were made to acquire this information, but a response was not received.There are a number of processes and checks to ensure that all product is adequately sterilized, inspected and released prior to shipment.The device ifu states: "intended for one time use only.This is a sterile device and should be stored at room temperature away from direct sunlight.If the product package is open or damaged when received, do not use this device.The shelf life of the product is 3 years from the date of manufacture." "infection may be introduced via needle puncture and result in urinary tract infection (uti), pelvic inflammatory disease (pid), uterine infection or cystitis." "carefully remove the needle from the packaging maintaining the sterility of the product.The sterile needle should be inspected for tip sharpness and kinking of any supplied tubing." due to the limited information received, it is difficult to determine a definitive root cause.It is possible that one or more of the following factors may have contributed to the complaint: change in procedural location/environment.Inexperienced operator.Infection control policy not adhered to damaged packaging after shipment causing contamination in device improper storage conditions causing contamination of devices.Other factors related to device handling or storage after shipment.Pma/510(k) granted on the 12 january 2018: k171625.The device was not returned for evaluation.A lot number was not provided for this complaint, therefore a review of the device history record could not be performed.Further information was requested from the healthcare facility to determine how the device may have contributed to the event.Three attempts were made to acquire this information, but a response was not received.There are a number of processes and checks to ensure that all product is adequately sterilized, inspected and released prior to shipment.The device ifu states: "intended for one time use only.This is a sterile device and should be stored at room temperature away from direct sunlight.If the product package is open or damaged when received, do not use this device.The shelf life of the product is 3 years from the date of manufacture." "infection may be introduced via needle puncture and result in urinary tract infection (uti), pelvic inflammatory disease (pid), uterine infection or cystitis." "carefully remove the needle from the packaging maintaining the sterility of the product.The sterile needle should be inspected for tip sharpness and kinking of any supplied tubing." due to the limited information received, it is difficult to determine a definitive root cause.It is possible that one or more of the following factors may have contributed to the complaint: change in procedural location/environment.Inexperienced operator.Infection control policy not adhered to.Damaged packaging after shipment causing contamination in device.Improper storage conditions causing contamination of devices.Other factors related to device handling or storage after shipment.

Event Description

The patient developed an infection (bilateral tubal ovarian abscess) after having an ovum aspiration (cyst aspiration) performed.

• 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: 7449889
• MDR Text Key: 106141932
• Report Number: 9680654-2018-00015
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OSN-1735-B-90-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1