MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-03 for MILEX UTERINE HANDY VAK SYSTEM * MX 507R6F manufactured by Milex Products, Inc..
[405292]
Upon receipt of the complaint, the failure mode could not be recreated using finished product of a different lot number, which was immediately available. An investigation team that included the medical officer opened devices and performed a functional test in an attempt to mimic the event. There were no unusual attributes in either the packaging of any operational forces required in the sample group. As with all customer complaints, trending for this particular failure continued. There were no statements or indications that injury had occurred in initial reports. 2. ) the product is a single-use 60cc syringe, sold in a sterile pouch, without cannula having a label name - milex 60cc handy-vak locking syringe. The annual distribution is 5,398 units, calculated september 2004 through august 2005. It has been determined through the course of this investigation that one lot only may present a concern in the marketplace. The total production for this batch is 496 devices. Distribution for this lot is confirmed at 496 devices and recovery from ordinary product returns is 135. Presently, 361 units either remain in the market or have been consumed. 3. ) labeling exhibits from lot 39608 are provided with this letter. This pre-amendment device has been on the market since well before 1977, as a milex product. Acquisition of milex by coopersurgical occurred in 2004. The facility closed in dec 2004, with operations transferred. 4. ) the device is a sterile, single-use, disposable syringe, sold 10 devices per box, appropriate lebeling appears on the outer box, and a direction for use is included in each box. Batch 39608 consists of 496 devices, of which 135 devices have been returned form one dissatisfied customer following routine return processing. Analysis of this return confirms a subtle resistance encountered when pulling on the piston, most likely due to an insufficient application of medical-grade silicone. These devices have been placed under quarantine pending final disposition. It is the intention of coopersurgical, inc. To contact the northeast district food and drug administration recall coordinator with the necessary information pertaining to initiation of removal for the balance of lot 39608 from the market, per 21cfr 806. 5. ) the verification of lot 39608 was not possible until product returns became available. Since the synringe is supplied without a cannula, it cannot definitely be determined that the syringe is the sole attributable cause. It is, however, possible that, in instances where the health care provider applies exceptional pulling forces, the piston can separate from the plunger in this lot. The result of a separation can lead to procedural complications while acquiring a tissue sample. As a matter of diligence, coopersurgical, inc. Contacted the reporting facility to insure that a direct line of communication is available to the health care center. The co's regulatory affairs department continues to monitor complaint notification per the co's procedure.
Patient Sequence No: 1, Text Type: D, B5
[426634]
Patient came to the er for vaginal bleeding. Patient was diagnosed with spontaneous abortion. A d&e was performed using the device. As with all of the other reports, the plastic part of the plunger disconnected from the rubber stopper, causing the cannula to advance into the uterus. Facility have attempted, unsuccessfully, several times to report this to the company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 626199 |
| MDR Report Key | 626199 |
| Date Received | 2005-08-03 |
| Date of Report | 2005-08-03 |
| Date of Event | 2005-08-01 |
| Report Date | 2005-08-03 |
| Date Reported to FDA | 2005-08-03 |
| Date Added to Maude | 2005-08-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILEX UTERINE HANDY VAK SYSTEM |
| Generic Name | SYRINGE |
| Product Code | HFC |
| Date Received | 2005-08-03 |
| Model Number | * |
| Catalog Number | MX 507R6F |
| Lot Number | 39498 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 615820 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 60634 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-03 |