MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-07-25 for WATER TRAP AD W/TWT VLV NS 50/CS 5275P manufactured by Carefusion.
[19222962]
The customer reported that "when using the 5276p with the 0p1775 circuit and a heated humidifier, after time and the circuit has heated up, the water trap will disconnect from the circuit. " they state that the connection is slick and loose.
Patient Sequence No: 1, Text Type: D, B5
[19447894]
(b)(4): results of investigation: there was no sample available for evaluation. However, an attempt to duplicate the failure reported with tubing (b)(4) to compare the suction force with the water trap 5275p according to the pull test results did not show a significant variance between the assemblies using both tubing. Therefore, the complaint was not confirmed. The device history record for the lot reported was evaluated for any issues related with this complaint. The product was manufactured, inspected and released in accordance with internal procedures and no issues were observed. The lot number reported by customer was reviewed and no anomalies were found. Our manufacturing process was reviewed and no problems were found related with the issue reported. Complaint identified for submission as an mdr following a retrospective review of (b)(4) self-manufactured complaints under capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2012-00194 |
| MDR Report Key | 2669383 |
| Report Source | 00 |
| Date Received | 2012-07-25 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-03-04 |
| Date Mfgr Received | 2010-03-04 |
| Date Added to Maude | 2012-11-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER TRAP AD W/TWT VLV NS 50/CS |
| Generic Name | DRAIN, TEE (WATER TRAP) |
| Product Code | BYH |
| Date Received | 2012-07-25 |
| Model Number | 5275P |
| Lot Number | Y09H1067 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-25 |