MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-01-12 for CATHETER, PERITONEAL manufactured by Covidien Mfg Solutions S.a..
[97072723]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[97072724]
As reported by the distributor, a small hole was found on the catheter outside the patient's body which led to peritonitis. The patient was hospitalized, and the doctor added cephalosporin to the patient's peritoneal dialysis solutions. The section of the catheter with the hole was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2018-00016 |
| MDR Report Key | 7185511 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2017-12-28 |
| Date Added to Maude | 2018-01-12 |
| 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 STREET |
| 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 |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2018-01-12 |
| 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 | 2018-01-12 |