MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-08 for PALINDROME 8888145044P manufactured by Covidien Mfg Solutions S.a..
[85372663]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[85372664]
The customer states during hemodialysis they found a hole in the catheter where the venous luer connector joins the silicone extension. The catheter was replaced and there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05290 |
| MDR Report Key | 6852050 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-08 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2015-05-11 |
| Date Added to Maude | 2017-09-08 |
| 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 | DIANE MATHEUS |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5085421480 |
| 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 | PALINDROME |
| Generic Name | CATHETER, HEMODIALYSIS, IMPLANTED, COATED |
| Product Code | NYU |
| Date Received | 2017-09-08 |
| Returned To Mfg | 2017-09-12 |
| Model Number | 8888145044P |
| Catalog Number | 8888145044P |
| Lot Number | 1512400103 |
| Device Expiration Date | 2018-04-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-08 |