MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2010-08-20 for 4 LEAD TUR IRRIGATION SET 2C4013 manufactured by Baxter Healthcare - Aibonito.
[1705748]
Customer reported a leakage from the set during priming. No patient injury or medical intervention occurred. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[8697951]
The reported condition of leak was confirmed. A visual inspection revealed the unit did not present any defects. The unit failed the functional test and pressure test at 8psi. The reported condition was confirmed. The most probable cause for the reported condition is related to an inadequate solvent bonding technique. An orientation was provided to all assemblers on (b)(4) 2010 related to the assembly process of the burette bottom cap to burette. A batch review could not be performed since the lot number is not available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000001-2010-02686 |
| MDR Report Key | 1810510 |
| Report Source | 00,01 |
| Date Received | 2010-08-20 |
| Date of Report | 2010-07-12 |
| Date of Event | 2010-07-09 |
| Date Mfgr Received | 2010-07-12 |
| Date Added to Maude | 2010-11-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - AIBONITO |
| Manufacturer Street | RD 721 KM 0 3 PO BOX 1389 |
| Manufacturer City | AIBONITO PR 705 |
| Manufacturer Postal Code | 705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4 LEAD TUR IRRIGATION SET |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2010-08-20 |
| Returned To Mfg | 2010-08-09 |
| Catalog Number | 2C4013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - AIBONITO |
| Manufacturer Address | RD 721 KM 0 3 PO BOX 1389 AIBONITO PR 705 705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-20 |