MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. WALLACE OOCYTE SET RECOVERY SYSTEM; MQE - NEEDLE, ASSISTED REPRODUCTION

Catalog Number ONS1733

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Pain (1994); Hospitalization required (2580)

Event Date 06/26/2013

Event Type  Injury  

Event Description

On (b)(4) 2013, the manufacturer submitted medwatch reports: 2183502-2013-00415 through 2183502-2013-00417 with regards to a report from a user facility that 3 pts reported to hospital reporting abdominal pain following egg collection procedure with the devices listed.The pts have recovered with no reported incident related medical sequela.Additional info has been received after the initial medwatch reports were submitted that indicated a fourth patient was also admitted to hospital following an egg collection procedure.According to reporter, the fourth pt was admitted to hospital care for abdominal pain and vomiting.During pt examination (laparoscopy and laparotomy), the pt was shown to have abdominal bleeding from the ovarian puncture site.Pt was given blood transfusion as a result.No permanent adverse effects reported.

Manufacturer Narrative

One product sample was received for evaluation.Visual evaluation of the returned needle found no deformities.Functional tip penetration testing found the product sample operated as intended and was within specification.There was no evidence found to suggest the event was caused from an intrinsic device problem.

• Brand Name: WALLACE OOCYTE SET RECOVERY SYSTEM
• Type of Device: MQE - NEEDLE, ASSISTED REPRODUCTION
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3650189
• MDR Text Key: 4287851
• Report Number: 2183502-2013-00927
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: ONS1733
• Device Lot Number: 2373715
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2014
• Distributor Facility Aware Date: 06/26/2013
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/26/2013
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: ONE PRODUCT SAMPLE WAS R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention