MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for P400 PREM U/M 16FR CATH SECURE P4P16SD manufactured by Covidien.
[133695688]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[133695689]
The customer reports that a patient was tugging on his foley catheter resulting in the catheter being severed, leaving part of it inside the patient? S bladder. The urology team was able to remove the foley tip from the patient's ureter at the bedside and a cystoscopy was not needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2019-02086 |
| MDR Report Key | 8264383 |
| Date Received | 2019-01-21 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2019-01-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | P400 PREM U/M 16FR CATH SECURE |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2019-01-21 |
| Model Number | P4P16SD |
| Catalog Number | P4P16SD |
| Lot Number | 813704862280 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-21 |