MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-08-08 for DYNDP160216 manufactured by Medline Industries, Inc..
[22680338]
It was reported that an rn attempted to remove the foley catheter and the balloon would not deflate. She withdrew approximately 2 ml of saline from the balloon and the tubing collapsed preventing any more saline to withdrawn. The rn cut the tubing but no saline came out. A urologist came in and attempted to burst the balloon with a guidewire with no success. The patient was taken to ultrasound where the catheter was successfully removed. The intervention taken in ultrasound to remove the catheter is not known. It is not known if the catheter was replaced. No other details were provided. The sample was not returned for evaluation. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
[22680339]
The balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2015-00068 |
| MDR Report Key | 4992210 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-08 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2015-07-06 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-08-11 |
| 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 | MS. DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FOLEY CATHETER, 16FR |
| Product Code | NWR |
| Date Received | 2015-08-08 |
| Catalog Number | DYNDP160216 |
| Lot Number | 15AB5942 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-08 |