MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for SUPRAPUBIC URINARY CATHETER DYND11756 manufactured by Medline Industries.
[63500135]
Home health rn received call from her patient stating the suprapubic catheter which was inserted earlier that day was cracked at the hub and urine was leaking. Patient was complaining of bladder spasms. Rn returned to patient's house the same day and attempted to remove catheter. The rn was unable to aspirate the water from the balloon of the 16fr/10cc catheter. The rn gently removed the catheter and the tip of the catheter was not visible. The patient was sent to the er where x-ray verified the catheter tip in the patient's bladder. The patient was referred to her urologist who removed the catheter tip via cystoscopy. Inserted and removed on (b)(6) 2017 by rn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066916 |
| MDR Report Key | 6208680 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-17 |
| Date Added to Maude | 2016-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPRAPUBIC URINARY CATHETER |
| Generic Name | SUPRAPUBIC URINARY CATHETER |
| Product Code | REF |
| Date Received | 2016-12-22 |
| Model Number | DYND11756 |
| Lot Number | 1210021600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |