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-1635-B-90

Device Problems Tear, Rip or Hole in Device Packaging (2385); Insufficient Information (3190)

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

Event Date 11/21/2023

Event Type  Injury  

Event Description

K-osn-1635-b-90 x10 ordered as demo sample by sales rep on 07.11.23 they were delivered to the sales rep who couldn¿t get to customer so the rep sent direct to the customer without opening the outer packaging.The sales rep didn¿t open box.Customer used 2 needles on patients before she noticed the label on the needles.She has reported to hfea in the uk as the label states they are non-sterile.No actual harm came about.Patients were informed of the incident.They received one dose of iv antibiotics and a course of oral antibiotics.They had a uss 5 days later.They remained clinically well.No signs of infection in egg/embryo dishes.Embryo development satisfactory.

Manufacturer Narrative

Although the two used devices will not be returned for evaluation, 8 unused devices will be returned to assist the investigation.

Event Description

K-osn-1635-b-90 x10 ordered as demo sample by sales rep on 07.11.2023.They were delivered to the sales rep who couldn't get to customer so the rep sent direct to the customer without opening the outer packaging.The sales rep didn't open box.Customer used 2 needles on patients before she noticed the label on the needles.She has reported to hfea in the uk as the label states they are non-sterile.No actual harm came about.Patients were informed of the incident.They received one dose of iv antibiotics and a course of oral antibiotics.They had a uss 5 days later.They remained clinically well.No signs of infection in egg/embryo dishes.Embryo development satisfactory.

Manufacturer Narrative

The clinician had used two of the demo samples on two patients and indicated that the other 8 x demo needles were not used.7 x unused devices from lot: a1140913 were returned for evaluation.During visual inspection it was confirmed that the devices all had the additional labelling (yellow demo label) affixed, and the sterile barrier of the packaging had a cut, indicating that these are demo devices and, consequently, should not be used on patients.Review of device history record (dhr) found that work orders for lot: a1140913 appear complete and correct.There were no temporary deviations or non-conformance's at the time of manufacturing.The associated inspection record confirms that the product was manufactured to specification.It has been established that the sales representative inadvertently ordered ¿demo samples¿ which are un-sterilised samples.This order was processed in the distribution centre where the non-sterile labelling was applied, and the samples were made un-sterile by cutting the sterile barrier packaging.The order was shipped directly to the sales representative; they did not open the box and as a result did not see the non-sterile labelling on the packages before shipping the package on to the customer.The customer appears to have opened the packaging of the devices without noting the non-sterile labelling on the packaging and then used 2 of the devices on patients.The laboratory team leader at the manufacturing facility was consulted on the reported event, and he stated the following: "i can say from the last few years of historical testing data in relation to our ivf needle range is that: 1.Our bioburden pre-sterilisation testing has remained consistently below 200 cfu/device.2.Our endotoxin testing has remained below 1 eu/device.¿ the complaint information was provided to the medical advisor in order to provide a clinical assessment, which stated the following: ¿accepting that the needles were initially sterilized after a routine manufacturing process restricts the possible organisms involved a lot.Haematogenous spread is not possible, and the risk of significant infections is reduced, but not zero, mainly due to the organisms that populate surfaces, not all of which are pathogenic.¿ additional information was received from a cook medical quality assurance senior manager."as per our global policy there are different types of orders for samples, the type of sample is to be communicated by the sales representative to customer support.In this case, a demo sample was requested.The order was correctly placed by the customer support (cs) team as a demo sample.The order went to the distribution centre to be fulfilled as a demo order, this means the products are selected from stock and they then go to get the additional labelling (yellow demo label) and to be de-sterilised which is breaking the sterile barrier with a cut.This was completed as per process.¿ the sales representative received the samples and sent them straight to the customer, the customer used the product and only saw the label after the use of two needles.Please note that a service complaint has been raised against the divisional sales group to assess for actions that can be taken with regards this issue.¿ the sales representative was retrained on the policy for ¿health care professional interactions - evaluation and demonstration products (samples) (evdm).Additionally, communication was sent out to all division and sales team members as a reminder of the distinctions between ordering a demo and/or sample.' a review of the manufacturing records and/or specifications did not reveal any discrepancies that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.A definitive root cause was identified.The reported event was caused due to the way the samples were ordered.As the term 'demo' was used, the needles were dispatched in an un-sterilized condition, and their packaging was intentionally cut.Unfortunately, the clinician was unaware of this distinction and overlooked the yellow label indicating their non-sterile status.A definitive root cause was identified.The reported event was caused due to the way the samples were ordered.As the term 'demo' was used, the needles were dispatched in an un-sterilized condition, and their packaging was intentionally cut.Unfortunately, the clinician was unaware of this distinction and overlooked the yellow label indicating their non-sterile status.

• 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 ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 18278987
• MDR Text Key: 329888626
• Report Number: 9680654-2023-00142
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• PMA/PMN Number: K983593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K-OSN-1635-B-90
• Device Lot Number: A1140913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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
• Patient Sex: Female