MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for 100% SIL TIEMANN 2WAY 5CC 171305160 manufactured by Teleflex Medical.
[40561028]
(b)(4). The device 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
[40561029]
Alleged event: the balloon is leaking and deflating quietly. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[42803865]
(b)(4). The device lot number provided does not exist with the product catalogue number; therefore, a dhr review could not be conducted. In our current standard operating procedure, the products are subjected to 100% visual inspection and leak test. Catheter with defective balloon will be culled out during this process. Leak balloon could happen due to various reasons. However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[42803866]
Alleged event: the balloon is leaking and deflating quietly. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2016-00044 |
| MDR Report Key | 5498236 |
| Date Received | 2016-03-14 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2016-04-14 |
| Date Added to Maude | 2016-03-14 |
| 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 |
| Generic Name | 100% SIL TIEMANN 2WAY 5CC |
| Product Code | FGH |
| Date Received | 2016-03-14 |
| Catalog Number | 171305160 |
| Lot Number | 15DG11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-03-14 |