MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-02 for TEMPERATURE SENSING 14F CATHETER DYND160814T manufactured by Medline Industries, Inc..
[4364535]
It was reported that three attempts were made to insert a catheter into a patient and each time the balloon ruptured.
Patient Sequence No: 1, Text Type: D, B5
[11729980]
The clinician inserted a foley catheter into a male patient in the icu. Three attempts with three separate catheters were made. The balloons were inflated with fluid and it was reported that each catheter fell out due to a ruptured balloon. The fourth catheter was inserted with no issue. No samples were retained for evaluation. The clinician stated no injury resulted. This is the first reported issue of this nature for this catheter. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00044 |
| MDR Report Key | 3802848 |
| Report Source | 05,06 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-30 |
| Date of Event | 2014-03-18 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-05-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPERATURE SENSING 14F CATHETER |
| Product Code | NWR |
| Date Received | 2014-05-02 |
| Catalog Number | DYND160814T |
| Lot Number | 13VB2708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-02 |