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

Catalog Number ON1733

Device Problem Physical Property Issue (3008)

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

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.Due to the pain and bleeding, the physician inspected the needle with a magnifying glass and observed irregularities in the bezel.During the puncture, nothing "strange" was noticed.The needles were compared to those of another lot, which did not present the bezel irregularity.Additional information has been requested multiple times, if received, a follow up will be sent.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Two used samples were received for investigation.Photographs were also provided for examination.A review of the provided photographs was unable to find defect with the devices.The initial device was received on october 21st, 2016; however the sample was determined to be a different part number than the reported device; therefore, no investigation was able to be performed.The second sample which was received on december 14th, 2016 was confirmed to be the reported part number and therefore an investigation was performed.The sample was received inside a plastic bag without the protector sheath to cover the tip.The returned sample was evaluated use a probe microscope; the sample was found to be within specification.During functional testing the sample underwent penetration evaluation; the sample was found to be within specification.Investigation determined that the sample operated within specification and no fault was found.Please note: initial sample was received on october 21st, 2016; however, it was determined to be the incorrect part number.The second sample was received on december 14th, 2016 and was found to be the correct part number.

Manufacturer Narrative

Two used wallace® wallace oocyte recovery systems samples were received for investigation.Photographs were also provided for examination.A review of the provided photographs was unable to find defect with the devices.The initial device was received inside a plastic bag on october 21st, 2016.The returned sample was evaluated using a probe microscope; no damage was observed with the device needle tip.A second sample was received inside a plastic bag on december 14th, 2016.The sample was received without the protective sheath to cover the tip.The second returned sample was also evaluated use a probe microscope; the sample was found to be within specification.During functional testing the sample underwent penetration evaluation; the sample was found to be within specification.Investigation determined that both returned samples operated within specification and no fault was found.Please note: initial sample was received on october 21st, 2016.The second sample was received on december 14th, 2016.

Manufacturer Narrative

Two used samples were received for investigation.Photographs were also provided for examination.A review of the provided photographs was unable to find defect with the devices.The initial device was received on october 21st, 2016; however the sample was determined to be a different part number than the reported device; therefore, no investigation was able to be performed.The second sample which was received on december 14th, 2016 was confirmed to be the reported part number and therefore an investigation was performed.The sample was received inside a plastic bag without the protector sheath to cover the tip.The returned sample was evaluated use a probe microscope; the sample was found to be within specification.During functional testing the sample underwent penetration evaluation; the sample was found to be within specification.Investigation determined that the sample operated within specification and no fault was found.Please note: initial sample was received on october 21st, 2016; however, it was determined to be the incorrect part number.The second sample was received on december 14th, 2016 and was found to be the correct part number.(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: 5866002
• MDR Text Key: 51772491
• Report Number: 2183502-2016-01687
• 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,Followup
• Report Date: 07/13/2016

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: 06/28/2019
• Device Catalogue Number: ON1733
• Device Lot Number: 2732535
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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