MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-07-14 for 100%SILICONE 2WAY 5CC 16FR 170605160 manufactured by Teleflex Medical.
[6437250]
Alleged event: after the catheter was inserted in the surgery theatre, the female patient lost the catheter a few days later while walking. The balloon split. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13769496]
(b)(4). The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[25528012]
(b)(4). The device lot number was not provided; therefore, a device history record (dhr) review could not be conducted. The returned sample appeared to be in a good condition except that the balloon was split. Closer examination on the split balloon area under dino-lite revealed scratch mark near the tear region. In our standard operating procedure the raw balloons are subjected to 100% visual inspection. Defective raw balloon will be culled out before sent to the next process. All foley catheters are subjected to leak test. Products that pass this test will be subjected to the next process. Based on the investigation and testing conducted on the actual sample, it is believed that the scratch mark found near the split area had initiated the tear. Therefore, we could not confirm this complaint as stated. No conclusion code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[25528013]
Alleged event: after the catheter was inserted in the surgery theatre, the female patient lost the catheter a few days later while walking. The balloon split. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00154 |
| MDR Report Key | 4913265 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-07-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 100%SILICONE 2WAY 5CC 16FR |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-14 |
| Returned To Mfg | 2015-07-14 |
| Catalog Number | 170605160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-14 |