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

Catalog Number ON1733

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

Patient Problems Abdominal Pain (1685); Blood Loss (2597)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Additional 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 a patient experienced severe abdominal pain and heavy bleeding after a puncture.Additional information has been requested multiple times, if received, a follow up will be sent.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Patient was born in 1971.(b)(4).

Event Description

Additional information: according to the reporter, it could not be determined the exact amount of blood lost; however, the patient lot "quite a lot".The patient received propofol and ibuprofen as treatment.The reported event resulted in hemoperitoneum and 3 days in hospital.

Manufacturer Narrative

Three used wallace® wallace oocyte recovery systems were received inside a plastic bag for investigation.Photographs were also provided for examination.A review of the provided photographs was unable to find defect with the devices, only the echogenic marks were observed.The returned samples were analyzed under microscopically to confirm if there was any damage to the needle tip.All returned samples were found to be within specification.During functional testing, the returned samples were penetration tested; all samples were found to be within specification.Investigation did not find fault with the returned samples and the samples were found to be within manufacturing specification.(b)(4).

• Brand Name: WALLACE OOCYTE RECOVERY SYSTEMS
• Type of Device: NEEDLE, ASSISTED REPRODUCTION
• Manufacturer (Section D): SMITHS MEDICAL; 1265 grey fox rd.; st paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; parque industrial monterrey; apodaca nl, cp 66603 ; MX 66603
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5866052
• MDR Text Key: 51774647
• Report Number: 2183502-2016-01690
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: ON1733
• Device Lot Number: 3003611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• 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): Other