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 2019-05-08 for HUDSON VENTILATOR TUBING SET,LONG LENGTH 1613 manufactured by Teleflex Medical.
[144440132]
(b)(4). The sample was not returned; however, the customer provided a photo for evaluation. A visual exam was performed and it was observed there was a type of cut in the tubing. No other issues were observed. The device history record of batch number 74a1901330 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No non-conformance reports were originated for the lot in question that can be associated to the complaint reported. The dhr shows that the product was assembled and inspected according to specifications. The complaint is confirmed based on the photo, however, the actual sample is needed to conduct a proper investigation and to determine a root cause. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[144440133]
The complaint is reported as: "crack found in circuit prior to set-up during leak test. Clinician kept the circuit and will send back for investigation. No further information was provided. " no patient harm or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00121 |
| MDR Report Key | 8591304 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2019-05-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON VENTILATOR TUBING SET,LONG LENGTH |
| Generic Name | CIRCUIT, BREATHING (W CONNECTO |
| Product Code | CAI |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-05-09 |
| Catalog Number | 1613 |
| Lot Number | 74A1901330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |