MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-07 for FOLEY CATHETER, 6FR, SILICONE DYND160806 manufactured by Medline Industries, Inc..
[14880555]
The catheter fell out and had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[15284015]
The catheter fell out and had to be replaced. There was no patient injury or need for additional medical intervention. The catheter was returned and the balloon was found to be ruptured. A root cause for the rupture is not known. The contact at the facility had very little information pertaining to the incident and stated she could not furnish any other details. The age and sex of the patient as well as the date of the incident was not reported. We do not know how much fluid was used to inflate the 1. 5 ml balloon. It is not known if user error may have played a role in the balloon rupture. Due to the need for a new catheter to be inserted, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00026 |
| MDR Report Key | 3674336 |
| Report Source | 05,06 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-03-03 |
| Date Mfgr Received | 2014-02-28 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2014-03-13 |
| 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 | 3 |
| 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 | FOLEY CATHETER, 6FR, SILICONE |
| Product Code | NWR |
| Date Received | 2014-03-07 |
| Catalog Number | DYND160806 |
| Lot Number | 120B0239 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-07 |