MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for 100%SILICONE 2WAY 5CC 16FR 170605160 manufactured by Teleflex Medical.
[40948935]
(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
[40948936]
Alleged event: the catheter was found broken between the connection and the tip used to inflate the balloon. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[43021616]
(b)(4). The device history review did not show issues related to the complaint. The visual examination of the sample showed that the catheter was broken in two parts. The sample was aligned and the total length was measured and met the specifications for this product. Both the shaft and the funnel were examined using the dino-lite to analyze the damaged area and torn edges. It was observed that the torn edges were jagged and there was excessive material at one side indicating that there is some external force applied at the joint area causing the catheter to break. The funnel portion revealed some cutting edges suggesting that the tube was once well attached to the funnel. No other nicks, abrasion, marks, or scratches were observed on the embedded shaft that could have likely caused the breakage. Other remarks: the manufacturer performed positive released tests at the injection molding process with representative samples using weight load testing to test the bonding strength between the funnel and tube prior to release. Based on the investigations no problem was found within the product which could have contributed from manufacturing processes. Therefore this complaint could not be confirmed. The root cause is unknown. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2016-00058 |
| MDR Report Key | 5510786 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-02-23 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-04-19 |
| Date Added to Maude | 2016-03-18 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| 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 |
| Product Code | FGH |
| Date Received | 2016-03-18 |
| Catalog Number | 170605160 |
| Lot Number | 15CE13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-18 |