MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-15 for OVUM PICK-UP ASPIRATION B BEVEL NEEDLE ONLY K-OPAA-1730 manufactured by William Cook Australia.
[18970339]
The pt started bleeding after using the needle. Add'l info rec'd 06/16/10: the hemorrhage needed surgical intervention to be stopped. Although requested, details of the surgical intervention performed and the pt outcome following this intervention have not been provided.
Patient Sequence No: 1, Text Type: D, B5
[18991524]
It was reported that the pt started bleeding/hemorrhaging after using the needle and surgical intervention was required to stop the bleeding. Add'l info regarding the details of the surgical intervention performed and the pt outcome following this intervention have been requested but have not been provided. The user facility is unsure of the specific lot number of the complaint device. No product was returned to assist in the investigation; however, the work orders for both lot numbers that have been shipped to this user facility were reviewed and found to be complete and correct. There are a number of qc checks in place during manufacture to ensure the needles meet specs. There is no evidence to suggest the device was not manufactured to specs. A definitive root cause of this occurrence cannot be determined; however, pt-related factors and user technique could have contributed to the event. In the ifu, it states "product, if used incorrectly, may cause needle stick injury" and "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. " based on a review of the complaints/sales data for all single lumen needles (b)(4) from (b)(6) 2005 through (b)(6) 2010, the incidence rate for reports of bleeding after using the needle is 0. 0002%. No corrective action required due to the low incidence rate. No product returned for eval, so a root cause could not be determined. Appropriate personnel have been notified and the mfr will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680654-2010-00001 |
| MDR Report Key | 1761637 |
| Report Source | 06 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-07-14 |
| Date Facility Aware | 2010-06-03 |
| Report Date | 2010-07-14 |
| Date Mfgr Received | 2010-06-16 |
| Date Added to Maude | 2010-07-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERNEEN GARDINER, MGR |
| Manufacturer Street | 95 BRANDL ST EIGHT MILE PLAINS |
| Manufacturer City | BRISBANE 4113 |
| Manufacturer Country | AS |
| Manufacturer Postal | 4113 |
| Manufacturer Phone | 33401872 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVUM PICK-UP ASPIRATION B BEVEL NEEDLE ONLY |
| Generic Name | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLE |
| Product Code | MQE |
| Date Received | 2010-07-15 |
| Model Number | NA |
| Catalog Number | K-OPAA-1730 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2010-07-15 |