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 2017-03-10 for DOVER 1213-02 manufactured by Mediquip (malaysia).
[69572750]
Submit date: 03/09/2017. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[69572751]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a urinary catheter. The customer states prior to use the balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
[87076439]
An investigation of the reported condition was performed. The sample was tested for inflation and deflation test using water and no problem observed. The catheter balloon can be deflated completely and the volume recovery for the deflation complies with the standard. Time taken for the sample to deflate surpassed the standard requirement for deflation and passed the requirement. Thus the deflation of the balloon was within the standard. Therefore, the reported condition cannot be confirmed as the reported incident cannot be duplicated and product was found functional. Since the reported condition could not be duplicated and the sample was able to be inflated and deflated normally, an actual root cause for the reported condition cannot be specifically identified. The reported condition could not be confirmed, thus corrective action will be limited to the manufacturing awareness issue. No further corrective action is required at this time. This complaint will be recorded for tracking and trending purpose. This 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. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[87076440]
The customer states prior to use, the cuff would not deflate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611712-2017-05002 |
| MDR Report Key | 6394578 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-10 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-06-19 |
| Date Added to Maude | 2017-03-10 |
| 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 (MALAYSIA) |
| 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 | 2017-03-10 |
| Returned To Mfg | 2017-04-26 |
| Model Number | 1213-02 |
| Catalog Number | 1213-02 |
| Lot Number | 6322B12QX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIQUIP (MALAYSIA) |
| Manufacturer Address | PADANG LATI, MUKIM PAYA KANGAR 01700 MY 01700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-10 |