MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for 100%SILICONE 2WAY 5CC 16FR 170605160 manufactured by Teleflex Medical.
[45151703]
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[45151704]
Reported event: particles, filament or small pieces of silicon were found on several catheters of several lot numbers of size 16. All lot numbers concerned have been quarantined. The patient condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[48200417]
(b)(4). Device history record batch card for the complaint lots were reviewed, and passed the qa inspection. Nine pieces of samples were returned for investigation. Based on complaint description, users have found particles of filament (or small pieces) of silicon in several catheters. Returned samples were carefully review using naked eye showing no abnormality. All other components were intact and in good condition other than the presence of small pieces of silicone along the catheter. Two samples contain visible traces of silicone along the catheters. All catheters were than further investigated using the dino-lite under 60x magnification and found out that 4 of the catheters were affected. The remaining 3 catheters were found to be clean. Based on the investigation conducted, 6 out of 9 samples were found to have silicone filament along the catheter. The correction action will be address through (b)(4) for further analysis. Therefore, this complaint is confirmed, as stated.
Patient Sequence No: 1, Text Type: N, H10
[48200418]
Reported event: particles, filament or small pieces of silicon were found on several catheters of several lot numbers of size 16. All lot numbers concerned have been quarantined. The patient condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2016-00070 |
| MDR Report Key | 5647091 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-14 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-05-11 |
| 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%SILICONE 2WAY 5CC 16FR |
| Product Code | FGH |
| Date Received | 2016-05-11 |
| Catalog Number | 170605160 |
| Lot Number | 15LE49 |
| 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 | 2016-05-11 |