MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-09-21 for SINGLE LUMEN OVUM PICK-UP NEEDLE K-OSN-1733-R-B-90 manufactured by William Cook Australia.
[2198378]
Initial information received: excessive amount of postoperative bleeding that required draining. The treatment had not changed nor the medication; the only thing they can attribute it to is the needle. No blood transfusion has taken place as of yet. Anywhere from 200 cc to 1500 cc of liquid requiring draining. The fluid is a mixture of blood and other secretions. Additional details received: six patients returned to (b)(6) clinic for follow-up appointments post transvaginal oocyte aspiration (between 14-37 eggs were collected) complaining of abdominal pain/fullness, and in some cases nausea/vomiting and increased pulse. Abdominal ultrasound was performed. If the patient was symptomatic and/or free fluid was observed in the pelvic/abdominal cavity, the patient was brought back for transvaginal aspiration of the fluid. After surgery, the patients were given iv fluids as well as iv albumin and medicated for pain and nausea. Patients were closely monitored after fluid drain. The initial information received indicated a date of event of (b)(6) 2011. However, as six patients are involved, it is unknown over what period of time this occurred.
Patient Sequence No: 1, Text Type: D, B5
[9349007]
Twenty-one unused needles from the same lot number were returned. Two were inspected with a microscope and had no obvious signs of degeneration of the tip or side bevels. There was no evidence of "dulling" of the cutting edges or deformation at the very tip of the needle where the facets meet. There was no evidence of any imperfections on the surface of the beveled tips. The work order is complete and correct and there is no evidence that the products were not manufactured to specification. There are a number of quality checks in place during manufacture that would most likely identify a blunt or damaged tip, and throughout manufacture the tip is covered with a tip protector or needle protector. The needles are also packed and shipped with a needle protector. The information reported by the complainant is suggestive of a known risk associated with an ovum aspiration procedure and possible effects of ovarian hyper stimulation syndrome, i. E. Bleeding and accumulation of fluid in the abdominal cavity following the procedure. It is not uncommon for fluid to accumulate and require drainage following this type of procedure. (b)(4). The manufacturer will continue to monitor for any emerging trends. No corrective action deemed necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680654-2011-00001 |
| MDR Report Key | 2265459 |
| Report Source | 08 |
| Date Received | 2011-09-21 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-08-23 |
| Date Mfgr Received | 2011-08-25 |
| Device Manufacturer Date | 2011-06-11 |
| Date Added to Maude | 2011-09-28 |
| 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, MANAGER |
| Manufacturer Street | 95 BRANDL STREET |
| Manufacturer City | EIGHT MILE PLAINS, 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 | SINGLE LUMEN OVUM PICK-UP NEEDLE |
| Generic Name | MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLE |
| Product Code | MQE |
| Date Received | 2011-09-21 |
| Returned To Mfg | 2011-09-14 |
| Model Number | NA |
| Catalog Number | K-OSN-1733-R-B-90 |
| Lot Number | A879975 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK AUSTRALIA |
| Manufacturer Address | BRISBANE AS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-09-21 |