MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-07-09 for HUDSON CIRCUIT,HTD DUAL LIMB W/WATER TRAPS W/O 780-36 manufactured by Teleflex Medical.
[6019034]
The customer alleges that a hole was detected in the device prior to patient use.
Patient Sequence No: 1, Text Type: D, B5
[14225189]
(b)(4). A dimensional, visual 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 74d1500709 that belong to catalog number 780-36 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. Dhr shows that the product was assembled & inspected according to our specifications. No corrective action can be established at this moment since the device sample is not available for evaluation. No picture available. Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time. If device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[23703312]
(b)(4). The reported complaint that the circuit has a hole in the circuit prior to use was confirmed through visual inspection of the returned sample. The hole was identified and noted on the expiratory limb. The device history record (dhr) of batch number 74d1500709 that belongs to catalog number 780-36 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. 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
[23703313]
The customer alleges that a hole was detected in the device prior to patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00184 |
| MDR Report Key | 4903441 |
| Report Source | 06,07 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2015-04-07 |
| Date Added to Maude | 2015-07-09 |
| 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 | 0 |
| Event Location | 0 |
| 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 CIRCUIT,HTD DUAL LIMB W/WATER TRAPS W/O |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-07-09 |
| Returned To Mfg | 2015-07-06 |
| Catalog Number | 780-36 |
| Lot Number | 74D1500709 |
| 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 | 2015-07-09 |