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 PED 3 CC 170003100 manufactured by Teleflex Medical.
[15907199]
Alleged event: the catheter was inserted preoperatively and was later found severed or broken at the y junction. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[16296182]
(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
[25528328]
(b)(4). The device lot number was not provided; therefore a dhr review could not be conducted. Visual examination was conducted on the returned sample and it was observed that the catheter was broken into two parts; one on shaft and the funnel. The returned sample was realigned and measured on the length of it using a calibrated ruler. It was observed that the overall length met the specification of this product. Then, both the catheter shaft and funnel were examined using the dino-lite to analyze the damaged area. Based on the observation the torn edges were jagged where more material was seen on one side of the catheter. Visual examination on the other areas of the catheter shaft did not reveal any sign of abrasion mark or scratch. There is no trace of nick or scratches on the embedded shaft. Based on the investigation conducted, the catheter was found to be broken. No other related issue within the manufacturing processes that could lead to defective product. Therefore this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[25528329]
Alleged event: the catheter was inserted preoperatively and was later found severed or broken at the y junction. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00158 |
| MDR Report Key | 4913107 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-05-13 |
| 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 PED 3 CC |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-14 |
| Returned To Mfg | 2015-07-14 |
| Catalog Number | 170003100 |
| 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 |