MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2013-11-15 for OVA-STIFF OVUM SINGLE LUMEN ASPIRATION NEEDLE K-OSN-1630-B-60-US manufactured by William Cook Australia.
[4112222]
During oocyte retrieval, the pt sustained bleeding. This happened on two occasions with two separate pts. Both complaint devices are from the same manufacturing lot. Stitches were required to stop the bleeding in the vaginal wall.
Patient Sequence No: 1, Text Type: D, B5
[11383899]
(dates of the events were not specified by the reporter). Although the actual complaint devices were discarded at the user facility, an unused device from the same lot number ahs been returned to the manufacturer for evaluation. (b)(4). Based on a review of the manufacturing records for this lot number, there is no evidence to indicate the devices were not manufactured to specification. Failure modes of the needle that could potentially contribute to bleeding include a blunt or damaged tip. There are a number of qc checks in place to identify a blunt or damaged tip. Throughout manufacturing, the needle tip is covered with a tip or needle protector and all devices are also packed and shipped with a needle protector. The instructions for use supplied with the product states "the sterile needle should be inspected for tip sharpness and kinked connecting tubing prior to pt contact. " it also states "vaginal bleeding has been reported to be associated with the transvaginal route for oocyte retrieval via needle aspiration. Bleeding is typically easily controlled with direct pressure. " it is possible that procedure and/or operator related factors have contributed to the adverse events. Note: an unused device from the same lot number has been returned by the user facility. Should inspection of this device indicate a deficiency or non-conformity has contributed to the adverse events, a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680654-2013-00011 |
| MDR Report Key | 3523428 |
| Report Source | 07,08 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-11-14 |
| Date Mfgr Received | 2013-10-17 |
| Device Manufacturer Date | 2013-02-06 |
| Date Added to Maude | 2013-12-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERNEEN GARDINER, MANAGER |
| Manufacturer Street | BRISBANE TECHNOLOGY PARK, 95 BRANDL STR |
| Manufacturer City | EIGHT MILE PLAINS, QLD AU 4113 |
| Manufacturer Country | AS |
| Manufacturer Postal | AU 4113 |
| Manufacturer Phone | 38411188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVA-STIFF OVUM SINGLE LUMEN ASPIRATION NEEDLE |
| Generic Name | NONE |
| Product Code | MQE |
| Date Received | 2013-11-15 |
| Returned To Mfg | 2013-11-12 |
| Model Number | NA |
| Catalog Number | K-OSN-1630-B-60-US |
| Lot Number | A915845 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK AUSTRALIA |
| Manufacturer Address | BRISBANE AS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-15 |