MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-18 for SILICONE ELASTOMER COATED LATEX CATHETER TRAY DYND160116 manufactured by Medline Industries, Inc..
[4354776]
The facility indicated they did not have an incident date but that the foley catheter balloon would not inflate and had to be reinserted.
Patient Sequence No: 1, Text Type: D, B5
[11574609]
The contact at the facility indicated that they were unsure of a date but that one of the nurses stated she attempted to inflate the balloon on two foley catheters for the same pt but was unsuccessful. The catheter apparently fell out. On the third attempt, she was successful. She discarded the catheter and did not initially report it. In the absence of a sample, we have not confirmed the issue and a root cause has not been determined. Due to the reported need for the catheter to be re-inserted, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00021 |
| MDR Report Key | 3659897 |
| Report Source | 05,06 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-13 |
| Date Mfgr Received | 2014-01-17 |
| Date Added to Maude | 2014-03-06 |
| 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 | JULINE 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 | 2014-02-18 |
| Catalog Number | DYND160116 |
| 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 | 2014-02-18 |