MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for 100% SIL TIEMANN 2WAY 5CC 171305160 manufactured by Teleflex Medical.
[24438259]
(b)(4). The device sample has not been returned to the manufacturer 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
[24438260]
Alleged event: the patient lost the catheter while being transferred to the toilet. There were no clinical consequences as a result of the incident. The catheter had been in place for nine days prior to the incident. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[29322587]
(b)(4). Additional method: device history record for lot (14fe26) was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. One actual sample was returned for investigation. Based on observation the balloon of the sample was split. A simulation test was conducted with representative samples from production on the same catheter size and balloon volume. No deflation issue was observed. Balloons are still inflated to its normal condition and shape. In our current standard operating procedure, the products are subjected to 100% visual inspection, and leak test. Any defective raw balloon will be culled out before being sent to the next process. Based on the investigation conducted, we could not link any process discrepancy that could lead to the balloon split issue. Therefore, we could not confirm the complaint, as stated.
Patient Sequence No: 1, Text Type: N, H10
[29322588]
Alleged event: the patient lost the catheter while being transferred to the toilet. There were no clinical consequences as a result of the incident. The catheter had been in place for nine days prior to the incident. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00175 |
| MDR Report Key | 5012245 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-18 |
| Date Mfgr Received | 2015-09-07 |
| Date Added to Maude | 2015-08-18 |
| 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 | 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 |
| Product Code | FGH |
| Date Received | 2015-08-18 |
| Returned To Mfg | 2015-08-24 |
| Catalog Number | 171305160 |
| Lot Number | 14FE26 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2015-08-18 |