MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-25 for IRRIGATION SET, Y-TYPE DYND19122 manufactured by Medline Industries, Inc..
[4441742]
Following a surgical repair of a nicked bladder, continuous bladder irrigation was initiated. The bladder ruptured again and the surgeon indicated he was not sure if the clinician or the equipment contributed to the incident.
Patient Sequence No: 1, Text Type: D, B5
[11845607]
Following the repair of a nicked bladder, the pt developed hematuria. Continuous bladder irrigation was initiated. Within 10 minutes, 3 liters of fluid had been infused into the bladder that was reported to be already weakened. Subsequently, the bladder ruptured and the pt was returned to the operating room. For surgical repair. The facility reported that the drip chamber filled completely and the nurse could not visualize the flow rate. There was no sample retained for evaluation as the incident occurred two weeks prior and was not reported at that time. We have had no other similar incidents reported to us. It is not known if the irrigation set was correctly primed with fluid prior to use. The reported amount of solution leaving the irrigation bag was significant and would be visually apparent to a clinician. The root cause appears to be clinician error. However, in an abundance of caution, this medwatch is being file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00041 |
| MDR Report Key | 3788306 |
| Report Source | 05,06 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2014-05-06 |
| 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 | IRRIGATION SET, Y-TYPE |
| Product Code | EYN |
| Date Received | 2014-04-25 |
| Catalog Number | DYND19122 |
| Lot Number | UNK |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-04-25 |