MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-12 for LATEX FOLEY CATHETER, 14F DYND160214 manufactured by Medline Industries, Inc..
[4293813]
The balloon did not fully deflate prior to withdrawal of the catheter.
Patient Sequence No: 1, Text Type: D, B5
[11603261]
The clinician was unable to withdraw all of the fluid from the foley catheter's balloon. A small top was applied and the catheter came out intact with the balloon partially inflated. The contact at the facility indicated that no serious injury resulted and no medical treatment was initiated as a result of the incident. The facility would not release the sample for eval. No photos were sent. We have not confirmed that any mfg defect existed. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00030 |
| MDR Report Key | 3693217 |
| Report Source | 05,06 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-03-13 |
| Date of Event | 2013-09-14 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-03-24 |
| 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 | 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 | LATEX FOLEY CATHETER, 14F |
| Product Code | NWR |
| Date Received | 2014-03-12 |
| Catalog Number | DYND160214 |
| Lot Number | 13EB6536 |
| 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. Required No Informationntervention | 2014-03-12 |