MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-10 for HUDSON VENTILATOR TUBING SET,W/WATER TRAPS,LON 1615 manufactured by Teleflex Medical.
[144728234]
(b)(4). One (1) 1615 ventilator tubing set, w/water traps, long, was received for investigation. The ventilator tubing set was visually inspected for any signs of abuse/misuse/damage. Nothing was noted. The dual limb 1615 ventilator tubing set, w/water traps, long was setup for leak test on a lab leak tester. Per iso standard 5367 annex e, the ventilator tubing set was tested at 60 +/- 3 cmh2o of pressure with incoming equipment pressure set a 30 psi. The acceptable leak value is = 30 ml/min. The actual ml/min pressure recorded was at least +80ml/min. The 1615 ventilator tubing set is leaking beyond the specified range , established in the iso acceptable parameters. The device history record of batch number 74k1801241 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. Based on the investigation performed, the reported complaint has been confirmed. Based on magnified visual inspection, it appears as though a sharp object came in contact with the blue tubing resulting in a sliced rib. Gas leakage cannot be measured due to the profuse volume of gas escaping. This product is inspected and tested 100% at the manufacturing site for leakage and any other physical damage noted. The dhr review did not uncover any manufacturing anomalies; therefore, it was determined that the incident is not manufacturing related. An actual root cause could not be established.
Patient Sequence No: 1, Text Type: N, H10
[144728235]
Customer complaint states: "rt attempted ventilator sst (short self test) and it failed the leak test. " alleged issue reported as occurred during pre-testing prior to a patient use. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00124 |
| MDR Report Key | 8600262 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2018-10-08 |
| Date Added to Maude | 2019-05-10 |
| 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 | 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,W/WATER TRAPS,LON |
| Generic Name | CIRCUIT, BREATHING (W CONNECTO |
| Product Code | CAI |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | 1615 |
| Lot Number | 74K1801241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-05-10 |