MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD WALLACE OOCYTE RECOVERY SYSTEMS; NEEDLE, ASSISTED REPRODUCTION

Model Number N/A

Device Problem Dull, Blunt (2407)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Distributor reported that the physician observed rough needle tips during oocyte recovery procedures.This was observed 15 times out of approximately 50 procedures.The patient's experienced internal bleeding, up to 600 mls, as well as 100-150 ml externally.As a result of the internal bleeding, all patients received hemostatic therapy.Some patient's required surgical treatment, including suturing of the ovary and puncture site.All of the patients recovered.Individual patient details were not provided.

Manufacturer Narrative

The reported wallace oocyte recovery set 17g, 10/ca used devices were destroyed.There were images provided by the customer, and it was observed that the tips of the needles were damaged.The complaints were confirmed the needle tip was observed to be damaged.(b)(4).

Manufacturer Narrative

Thirty unused wallace oocyte recovery systems were returned for evaluation.Visual inspection found that the needle protector were in good condition to assure safe handling.Microscopic visual inspection found no damage and that the devices were found within specification.Functional testing involved a penetration test and all samples were found within specification.Retained samples from a different lot were visually and functionally tested and were found within specification.A gage repeatability and reproducibility study was performed on the part and all personnel detected damaged devices appropriately.Photos of the actual devices were provided by the customer and it was observed that the tips of the needle were damaged.Based on the evidence, the root cause was unable to be determined and all returned and retained devices were found within specification.The complaint was confirmed based on the observed photographic evidence.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.

• Brand Name: WALLACE OOCYTE RECOVERY SYSTEMS
• Type of Device: NEEDLE, ASSISTED REPRODUCTION
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD; mark upton; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st paul 55112 ; 7633833052
• MDR Report Key: 5745473
• MDR Text Key: 48051567
• Report Number: 2183502-2016-01245
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K000628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/28/2020
• Device Model Number: N/A
• Device Catalogue Number: ON1733
• Device Lot Number: 3003611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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 Outcome(s): Required Intervention