MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-06 for HUDSON TRACH ADAPTOR 2415-01 manufactured by Teleflex Medical.
[64065965]
(b)(4). The investigation into this complaint is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[64065966]
Customer complaint alleges "tubing on the cannula has holes. " alleged defect detected during use. No harm or injury to the patient. Patient condition reported as "fine. "
Patient Sequence No: 1, Text Type: D, B5
[69118560]
(b)(4). The actual sample involved in the reported complaint was not returned for evaluation; therefore, the complaint could not be confirmed. In the current manufacturing procedure 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release from the manufacturing facility. As the actual sample was not returned, ten samples of the same catalog number were selected from current production at the manufacturing facility. A visual exam was performed and no defects were observed. In addition, the samples were leak tested and no issues were detected. It is possible that this defect occurred due to mishandling of the product. The failure was reported during use on a patient. The tube must be soft and flexible in order to meet the hfnc oxygen therapy and user requirement; thus it is prone to tears and pin holes when it is over pulled and stretched. The instructions for use (ifu) mentions that the tubing should not be stretched to remove condensation, or damage/malfunction may occur.
Patient Sequence No: 1, Text Type: N, H10
[69118561]
Customer complaint alleges "tubing on the cannula has holes. " alleged defect detected during use. No harm or injury to the patient. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2017-00019 |
| MDR Report Key | 6229380 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-02-16 |
| Date Added to Maude | 2017-01-06 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| 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 | HUDSON TRACH ADAPTOR |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-01-06 |
| Catalog Number | 2415-01 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2017-01-06 |