MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08,distributor,foreign, report with the FDA on 2015-07-01 for HUDSON UNIVERSAL VENTILATOR TUBING SET,W/WATER 1617 manufactured by Teleflex Medical.
[6063630]
The customer alleges that there is a hole in the circuit which is generating a leak during the pre-testing. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13706230]
(b)(4). The complaint was confirmed, but the root cause is unknown. One picture of a section of the product catalog number 1617 (universal ventilator tubing set,w/water) was received for analysis. It was visually inspected founding holes on a section of the corrugated tubing. No other issues were found. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record (dhr) of batch number 02m1300872 that belong to catalog number 1617 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. The dhr shows that the product was assembled and inspected according to our specifications. The customer complaint was confirmed based on the visual inspection performed to the picture received, holes on a section of the corrugated tubing were detected, at present time it is not possible to determine in which part of the supply chain process the material is being damaged since this condition it is 100% tested at production line on tp-0145 (leak test). Other remarks: however the current inventory that is in (b)(4) (universal ventilator tubing set,w/water) related to this complaint notification was inspected by the defect of "hole in the circuit" as it is describe on this customer complaint, and no issues were detected. If device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[22998318]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that there were holes in the corrugated tubing. Functional testing was performed and it was determined that there was an air leak. Based on the investigation performed, the reported complaint was confirmed. Dhr shows that the product was assembled and inspected according to specification. It is unknown how the circuit was handled prior to use. The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[22998319]
The customer alleges that there is a hole in the circuit which is generating a leak during the pre-testing. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00176 |
| MDR Report Key | 4883738 |
| Report Source | 01,06,08,DISTRIBUTOR,FOREIGN, |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-19 |
| Date of Event | 2015-04-28 |
| Date Mfgr Received | 2015-07-31 |
| Device Manufacturer Date | 2013-12-05 |
| Date Added to Maude | 2015-07-01 |
| 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 UNIVERSAL VENTILATOR TUBING SET,W/WATER |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-07-06 |
| Catalog Number | 1617 |
| Lot Number | 02M1300872 |
| 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 | 2015-07-01 |