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 2017-05-30 for PALINDROME UNK DY manufactured by Covidien Mfg Solutions S.a..
[76154721]
Submit date: 2017/may/30. An investigation is currently underway; upon completion the results will be forwarded. 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
[76154722]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states the patient returned to the facility for dialysis in the eighth week after insertion of the catheter and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5
[130363812]
An investigation was performed. Since no lot number was identified, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since a sample, picture or video were not received for testing; therefore the reported issue is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes. The line was discarded by the patient/renal nurses since it is a single use item. No photos available. The cuff was completely out with no signs of fibrosis to the patient's tissue after 6 weeks sutured. No tract infections and sutures removed at 6 weeks. Female, (b)(6) yrs, right jugular line - 23cms, line slipped out in the 8th week. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[130363813]
The customer states the patient returned to the facility for dialysis in the eighth week after insertion of the catheter and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05144 |
| MDR Report Key | 6597622 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-03 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-05-30 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 0101 |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALINDROME |
| Generic Name | CATHETER, PERITONEAL DIALYSIS, SINGLE USE |
| Product Code | FKO |
| Date Received | 2017-05-30 |
| Model Number | UNK DY |
| Catalog Number | UNK DY |
| Lot Number | UNKNOWN |
| 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 0101 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |