MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-21 for MAJOR UROLOGY KIT CDS98132IN manufactured by Medline Industries, Inc..
[4450922]
The foley catheter balloons ruptured after a few days.
Patient Sequence No: 1, Text Type: D, B5
[12013837]
The surgery tech at the facility reported that during the previous 45 days, they experienced 6 incidents of foley catheter balloon ruptures approximately 3-5 days post operatively. He did not have dates of the incidents but indicated all were male pts who were status post prostatectomy and reconstructive surgical procedures. He acknowledged the foley catheter balloons were inflated with 15ml of fluid despite the stated balloon capacity of 10ml. No samples were retained for evaluation and the lot numbers of the catheters are not known. The catheters were not replaced following the balloon rapture. He could not confirm any injury or negative consequence that resulted from the incident but stated that three patients returned for subsequent procedures. It is not confirmed if the absence of a catheter caused or contributed to the post op complications. A root cause has not been determined but due to the facility's practice of inflating the balloons to 15ml, recommendations have been made for them to consider utilizing foley catheters with larger balloon capacities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423395-2014-00010 |
| MDR Report Key | 3836236 |
| Report Source | 05,06 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-05-16 |
| Date Mfgr Received | 2014-04-17 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-05-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MAJOR UROLOGY KIT |
| Product Code | NWR |
| Date Received | 2014-05-21 |
| Catalog Number | CDS98132IN |
| Lot Number | 12IB9559 |
| 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 | 2014-05-21 |