MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-09-05 for RUSCH FILIFORM SPIRAL TIP 4FR 343104 manufactured by Teleflex Medical.
[17970708]
The event is reported as: "customer reported the following: the staff was using this device to help insert the foley catheter into the pt when the metal fell off inside the pt. A cystoscopy had to be performed to retrieve the part and pt is ok. " no pt injury reported. Pt current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[18051795]
Per device history report (dhr), investigation did not show issues related to this complaint. Dhr shows that the product was packed and inspected according to our specs. No corrective action can be established since the defective sample was not received for eval. No conclusion can be established at this time based on the lack of defective sample. It is necessary to have the physical sample in order to perform a proper investigation. The mfr will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2012-00266 |
| MDR Report Key | 2739499 |
| Report Source | 05,06,07 |
| Date Received | 2012-09-05 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-08-19 |
| Date Mfgr Received | 2012-08-29 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-12-19 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH FILIFORM SPIRAL TIP 4FR |
| Generic Name | FILIFORM SPIRAL TIP |
| Product Code | FBW |
| Date Received | 2012-09-05 |
| Catalog Number | 343104 |
| Lot Number | 02C0902908 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-05 |