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 2017-10-23 for PALINDROME 8888541123 manufactured by Covidien Mfg Solutions S.a..
[90684271]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90684272]
According to the reporter, on (b)(6), during hemodialysis the device? S arterial luer adapter became detached from the(bionic) extension lines. The luer adapter had to be reconnected on the arterial line. It was suspected that the patient was disconnecting the arterial lines. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05331 |
| MDR Report Key | 6968357 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-23 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2015-01-09 |
| Date Added to Maude | 2017-10-23 |
| 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 | KIT, REPAIR, CATHETER, HEMODIALYSIS |
| Product Code | NFK |
| Date Received | 2017-10-23 |
| Model Number | 8888541123 |
| Catalog Number | 8888541123 |
| Lot Number | 1428800041 |
| Device Expiration Date | 2019-12-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-10-23 |