MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-22 for UNKNOWN PERITONEAL CATHETER UNK PD manufactured by Covidien Mfg Solutions S.a..
[92781709]
The site has indicated that the incident sample has been discarded. If additional information pertinent to the incident is obtained, a follow-up report will be submitted. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92781710]
It is reported by baxter that a customer found a rupture in the catheter near the titanium joint which was causing leaks and abdominal pain to the patient. The ruptured catheter tube lead to an infection. The patient was treated in the hospital, the tube has been removed and dialysis was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05360 |
| MDR Report Key | 7053576 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JACQUELINE ST. PIERRE |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524938 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PERITONEAL CATHETER |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-11-22 |
| Model Number | UNK PD |
| Catalog Number | UNK PD |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-22 |