MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for SUPRAFLEX SUPRAPUBIC 12F 170703120 manufactured by Teleflex Medical.
[65464508]
(b)(4). The device investigation report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[65464509]
The device was inserted into the patient 40 days before of the incident. The device came out of the patient and the balloon had deflated. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[66165410]
Qn#(b)(4). The device lot number was not provided; therefore a dhr review could not be conducted. One actual sample was returned for investigation. Based on the complaint description, it was reported that the balloon was slipped out from the patient and found that the balloon was deflated. Investigation was conducted by inflating the sample returned with 10ml of red color water and left on the work bench for a period of 20 minutes. The balloon stayed inflated to its normal condition and shape. No deflation issue or leak balloon was observed along the catheter. Also, the sample can be inflated and deflated successfully with no issue. Balloon deflation could happen due to various reasons such as leakage at the balloon, shaft or funnel areas. Valve malfunction also could contribute to this balloon deflation issue. In current standard operating procedure, the balloons are subjected to 100% visual inspection and any defective raw balloon noticed will be culled out before proceed to the next process. Upon completion of assembly process, the catheter will be then subjected to 100% balloon inspection and 20 minutes leak test. Any catheter with defective balloon will be culled out during this process. Other remarks: based on the investigation conducted, no leak balloon found on the returned sample. The balloon can be inflated and deflated with no issue. Therefore, this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[66165411]
The device was inserted into the patient 40 days before of the incident. The device came out of the patient and the balloon had deflated. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2017-00001 |
| MDR Report Key | 6256177 |
| Date Received | 2017-01-17 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-18 |
| Date Mfgr Received | 2017-01-26 |
| Date Added to Maude | 2017-01-17 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPRAFLEX SUPRAPUBIC 12F |
| Product Code | KOB |
| Date Received | 2017-01-17 |
| Returned To Mfg | 2017-01-06 |
| Catalog Number | 170703120 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-17 |