MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-10-30 for DOUBLE LUMEN OVUM ASPIRATION NEEDLE K-0PSD-1633-A-S-US manufactured by William Cook Australia.
[4996665]
It was reported that excessive bleeding occurred in multiple cases (exact number still to be determined) with the use of needles from this particular batch, allegedly due to the needles being too sharp. No specific event date or information was provided for each case. The pt was either cauterized, sutured, or extended pressure was applied to stop the bleeding.
Patient Sequence No: 1, Text Type: D, B5
[12459579]
Udi#: (b)(4). Investigation still in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680654-2014-00025 |
| MDR Report Key | 4235949 |
| Report Source | 08 |
| Date Received | 2014-10-30 |
| Date of Report | 2014-10-28 |
| Date Mfgr Received | 2014-09-30 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-11-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERNEEN GARDINER, MGR |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLE LUMEN OVUM ASPIRATION NEEDLE |
| Generic Name | NONE |
| Product Code | MQE |
| Date Received | 2014-10-30 |
| Returned To Mfg | 2014-10-07 |
| Catalog Number | K-0PSD-1633-A-S-US |
| Lot Number | A932535 |
| Device Expiration Date | 2017-02-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-10-30 |