MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for DOVER 1213-02 manufactured by Mediquip.
[69560544]
Submit date: 03/07/2017. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[69560545]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a urinary catheter. The customer states the balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
[96738670]
No sample was received for the evaluation. The investigation was based on the trend analysis and batch history review only. Further investigation on the sample could not be conducted. The reported condition could not be confirmed. Since no trend exists, an actual root cause for the reported condition cannot be specifically identified. A review of the device history record (dhr) was done. The lot was manufactured as per the defined device master record. All acceptance criteria were met and this batch was released meeting all the acceptance criteria. The probable root cause for non-deflation usually is associated with uneven rib balloon thickness due to the ribbed of the former balloon has worn out. The pressure from the water pressing on the lumen of the catheter could have led to excess water inside the balloon which could not flow out through the eye. Since no trend exists, an actual root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[96738671]
The customer states the balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611712-2017-05001 |
| MDR Report Key | 6383441 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-06-19 |
| Date Added to Maude | 2017-03-07 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | MEDIQUIP |
| Manufacturer Street | PADANG LATI, MUKIM PAYA |
| Manufacturer City | KANGAR 01700 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 01700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOVER |
| Generic Name | KIT, CATHETER, URINARY (EXLUDES HIV TESTING) |
| Product Code | NWO |
| Date Received | 2017-03-07 |
| Model Number | 1213-02 |
| Catalog Number | 1213-02 |
| Lot Number | 3179074QX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIQUIP |
| Manufacturer Address | PADANG LATI, MUKIM PAYA KANGAR 01700 MY 01700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-07 |