MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-13 for SILICONE ELASTOMER COATED LATEX CATHETER TRAY DYND160116 manufactured by Medline Industries, Inc..
[20781613]
The catheter balloon would not inflate. A new catheter was then inserted without further incident.
Patient Sequence No: 1, Text Type: D, B5
[21001973]
Prior to the insertion of the foley catheter, the clinician tested the balloon by inflating it with 10 ml of saline. It apparently inflated and deflated without issue. She then inserted the catheter and attempted to inflate the balloon. After inserting 5 ml of saline, she noticed a bulging at the y of the tubing. She removed the catheter and then inserted a new catheter without further incident. The sample was returned and evaluated. The inflation lumen was found to be collapsed which prevented the inflation of the balloon. The root cause for the collapse was not determined. We pulled samples from stock and tested them. We were unable to replicate the reported issue. The balloons were tested and all inflated and deflated according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00001 |
| MDR Report Key | 3708940 |
| Report Source | 06 |
| Date Received | 2014-01-13 |
| Date of Report | 2014-01-03 |
| Date of Event | 2013-12-05 |
| Date Mfgr Received | 2013-12-05 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-03-31 |
| 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 | RISK MANAGER |
| 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 | SILICONE ELASTOMER COATED LATEX CATHETER TRAY |
| Product Code | NWR |
| Date Received | 2014-01-13 |
| Catalog Number | DYND160116 |
| Lot Number | 13HB4297 |
| 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 | 2014-01-13 |