MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-14 for 100% SIL TIEMANN 2WAY 5CC 171305160 manufactured by Teleflex Medical.
[24295295]
(b)(4). The device sample has been returned to the manufacturer but the investigation report has not been submitted at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[24295296]
Alleged event: the balloon was reported to be torn. The catheter was being used on the patient for urinary drainage. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[29841806]
(b)(4). The device history record was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. The 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 marks near the tear region. In our standard operating procedure, the raw balloons are subjected to 100% visual inspection using magnification lens. Defective raw balloon will be culled out before sent to the next process. After assembly, all foley catheters are then subjected to leak test. Product that passed this test will be subjected to the next process. Based on the investigation conducted on the actual sample, it is believed that the scratch marks found near the split area had initiated the tear. Therefore, we could not confirm this complaint as stated.
Patient Sequence No: 1, Text Type: N, H10
[29841807]
Alleged event: the balloon was reported to be torn. The catheter was being used on the patient for urinary drainage. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00173 |
| MDR Report Key | 5005467 |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-17 |
| Date Added to Maude | 2015-08-14 |
| 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 | 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 | 100% SIL TIEMANN 2WAY 5CC |
| Product Code | FGH |
| Date Received | 2015-08-14 |
| Returned To Mfg | 2015-07-14 |
| Catalog Number | 171305160 |
| Lot Number | 14KE46 |
| 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 | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |