MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for CURITY MONO-FLO 14FR WO PVPI 6162MF manufactured by Covidien.
[188514822]
(b)(4). 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
[188514843]
The customer reported that a (b)(6) male patient underwent a hernia surgery on (b)(6) 2020. At 12 pm, the catheter was indwelled and the balloon was checked and performed without problems. At 9 pm, it was found that the catheter had come out on its own. Upon visual inspection of the catheter tip, the balloon seemed to be partially missing and it was assumed there might be fragments of the balloon inside the patient so the doctor confirmed it with a cystoscope. The result was no piece of balloon/catheter was left inside the patient. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2020-02422 |
| MDR Report Key | 9764805 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-27 |
| 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 | 5086183640 |
| 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 | 3 |
| Brand Name | CURITY MONO-FLO 14FR WO PVPI |
| Generic Name | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER |
| Product Code | KNX |
| Date Received | 2020-02-27 |
| Model Number | 6162MF |
| Catalog Number | 6162MF |
| Lot Number | 1918346364 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-27 |