MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for SILICONE TOTAL ONE LAYER FOLEY CATHETER TRAY URO170816S manufactured by Medline Industries Inc.
[45923770]
Patient Sequence No: 1, Text Type: N, H10
[45923771]
The nurse stated when she went to take a sample from the port, the port broke off of the main tubing. The product was not saved but pictures were taken. Manufacturer response for urological tubing, medline (per site reporter): the sales rep asked for the pictures that were taken and they were sent. The next day the rep asked to inspect our lot #'s. The rep stated medline had made some modifications to the product and medline would like to change out certain lot #'s if we have them on hand. (at this time the lot #s are still unknown to us).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5678174 |
| MDR Report Key | 5678174 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-04-17 |
| Report Date | 2016-05-05 |
| Date Reported to FDA | 2016-05-05 |
| Date Reported to Mfgr | 2016-05-05 |
| Date Added to Maude | 2016-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE TOTAL ONE LAYER FOLEY CATHETER TRAY |
| Generic Name | KIT, URINARY CATHETER |
| Product Code | NWR |
| Date Received | 2016-05-25 |
| Model Number | URO170816S |
| Catalog Number | URO170816S |
| Lot Number | 15KB0133 (POSSIBLE LOT) |
| ID Number | RJ15/ 77469 |
| Device Expiration Date | 2016-12-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-25 |