MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-09 for FOLEY CATHETER, 16F DYND160816S manufactured by Medline Industries, Inc..
[3572002]
During a cystoscopy, the tip of the foley catheter was found in the bladder.
Patient Sequence No: 1, Text Type: D, B5
[10900179]
It was reported that the catheter was removed during a surgical procedure in order to insert a cystoscope. During the cystoscopy, a foreign object was visualized in the bladder and was determined to be the tip of the foley catheter. The sample was not returned for eval but was described as measuring about 3-4 inches in length. The risk manager did not know what procedure was being performed or if any surgical instruments could have possibly damaged the integrity of the catheter. We have not had a similar incident reported to us for this catheter. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00058 |
| MDR Report Key | 3232261 |
| Report Source | 05,06 |
| Date Received | 2013-07-09 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-05-30 |
| Date Mfgr Received | 2013-06-11 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-07-18 |
| 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 | FOLEY CATHETER, 16F |
| Product Code | NWR |
| Date Received | 2013-07-09 |
| Catalog Number | DYND160816S |
| Lot Number | 12LB7632 |
| 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 | 2013-07-09 |