MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-07-14 for 6FR 100% SILICONE FOLEY 170003060 manufactured by Teleflex Medical.
[6050479]
Alleged event: the catheter was pre-tested per facility protocol without issue but a day after insertion, the catheter broke at the juncture of the lumen and lumen hub. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[14205408]
(b)(4). The device sample has been returned to the manufacturer however 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
[23972326]
(b)(4). The device history records (lot 12ce14, 11ge32 & 121e40) were reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. From visual observation on the representative samples, no issue was found. All components were intact and in good condition. Based on the report statement, a catheter was found broken at the junction of the tube, a day after insertion. To confirm device is functioning well, funnel detachment test was conducted to determine the bonding strength between funnel and shaft of the representative sample. In addition, (b)(4) pieces of production samples inclusive of representative samples were picked for funnel detachment test. Based on the findings, all tested samples met the minimum requirement of 7. 5n and no other findings within the product, which could have contributed from manufacturing processes. In the absence of the actual samples, we could not conduct further investigation to associate the nature of the failure with any manufacturing inadequacy. Therefore this complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[23972327]
Alleged event: the catheter was pre-tested per facility protocol without issue but a day after insertion, the catheter broke at the juncture of the lumen and lumen hub. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00148 |
| MDR Report Key | 4912570 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-06-18 |
| Date Mfgr Received | 2015-08-18 |
| 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 | 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 | 6FR 100% SILICONE FOLEY |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-07-14 |
| Returned To Mfg | 2015-07-21 |
| Catalog Number | 170003060 |
| Lot Number | 12CE14 |
| 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 | 2015-07-14 |