MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-12-23 for PALINDROME EMERALD 23/40 KIT 8888145044C manufactured by Covidien.
[15320218]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter. The customer reports that a diabetic patient on (b)(6) 2014 had a palindrome h catheter 23/40 in inserted in the vena jugularis interna. On (b)(6) 2014 the patient coughs and low flow occurs. It was found that the cuff is 2cm exposed outside the exit site. Sutures were not removed but loosened during coughing. The catheter is removed and a new catheter placed on a later date. Medical intervention was required but there no date or details available on the intervention, procedure duration was 1. 5 hours.
Patient Sequence No: 1, Text Type: D, B5
[15667292]
(b)(4). An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[25270594]
The manufacturing lot number associated with this complaint was not provided. Without the lot number, a device history record (dhr) review could not be performed. All dhrs are reviewed for accuracy prior to product release. The complaint sample was not returned to the manufacturing site for review. Without the sample, it is not possible to determine a confirmed root cause of this issue. Should the sample be returned in the future, this complaint will be re-opened for further investigation. Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary. 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 in place to prevent nonconforming product from leaving the manufacturing operations. This information will be utilized for tracking and trending purposes to determine the need for corrective action. A corrective action is not warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2014-00205 |
| MDR Report Key | 4359391 |
| Report Source | 01,06 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2015-05-08 |
| Date Added to Maude | 2015-01-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALINDROME EMERALD 23/40 KIT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2014-12-23 |
| Model Number | 8888145044C |
| Catalog Number | 8888145044C |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |