MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-08-10 for WALLACE OOCYTE RECOVERY SYSTEMS ON1733 manufactured by Smiths Medical.
[51772491]
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.
Patient Sequence No: 1, Text Type: N, H10
[51772492]
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.
Patient Sequence No: 1, Text Type: D, B5
[60765468]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67462422]
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.
Patient Sequence No: 1, Text Type: N, H10
[67463554]
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.
Patient Sequence No: 1, Text Type: N, H10
[67466602]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2016-01687 |
| MDR Report Key | 5866002 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-13 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-08-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA PERZ |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST PAUL 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V |
| Manufacturer Street | CARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY |
| Manufacturer City | APODACA NL, CP 66603 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 66603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE OOCYTE RECOVERY SYSTEMS |
| Generic Name | NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2016-08-10 |
| Catalog Number | ON1733 |
| Lot Number | 2732535 |
| Device Expiration Date | 2019-06-28 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | 1265 GREY FOX RD. ST PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-10 |