MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-05-21 for TUR IRRIGATION SET Y-TYPE 06543 manufactured by Abbott Laboratories.
[274866]
An undocumented number of incidents of irrigation tubing set disconnection and splitting. The customer reported that during cystoscopy procedures, the distal end of the tubing sets are becoming disconnected from the stopcock. There was no pt specific or event data provided. It was reported that on one occasion the surgeon and monitor were sprayed with an unspecified fluid. The reporter stated that when the distal end of the tubing set comes in contact with fluid, the distal end of the tubing becomes loose. This is especially noted to occur when the scopes are changed and the tubing is attached elsewhere. The tubing then splits approximately 1/4th of an inch along the longitudinal lines on the distal end of the set. There was no reported pt adverse pt event. Although requested, no additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2003-00092 |
| MDR Report Key | 462437 |
| Report Source | 05 |
| Date Received | 2003-05-21 |
| Date of Report | 2003-05-06 |
| Date of Event | 2003-05-01 |
| Date Mfgr Received | 2003-05-06 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2003-05-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA, ASSOCIATE DIR. |
| Manufacturer Street | 200 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUR IRRIGATION SET Y-TYPE |
| Generic Name | INRRIGATION SET |
| Product Code | EYZ |
| Date Received | 2003-05-21 |
| Returned To Mfg | 2003-05-14 |
| Model Number | NA |
| Catalog Number | 06543 |
| Lot Number | 920875H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 451386 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | P.O. BOX 212-3006 BARREAL DE HEREDIA CS |
| Baseline Brand Name | TUR IRRIGATION SET Y-TYPE |
| Baseline Generic Name | IRRIGATION SET |
| Baseline Model No | NA |
| Baseline Catalog No | 06543 |
| Baseline ID | NA |
| Baseline Device Family | SYSTEM, URINE DRAINAGE, CLOSED |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-21 |