MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-26 for HUDSON ADAPTOR,CUFF,22MM ID 1421 manufactured by Teleflex Medical.
[76199292]
(b)(4). A visual inspection of the device involved in the complaint was performed on a picture provided by the customer. However this picture is not clear enough to confirm this customer complaint. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned at the time of this report. A device history record review shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. Visual inspection of the product involved in the complaint was performed on a picture provided by the customer and it is not clear enough to confirm this customer complaint. To perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint. However material from the production line was verified and no issues were found that can lead this customer complaint. If the device sample becomes available at a later date, this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[76199293]
Customer complaint alleges "believes they are having issues with carefusion or teleflex products depositing shards of plastic in the circuits". Alleged defect reported as detected during use. It was reported there was no patient injury or necessary medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00221 |
| MDR Report Key | 6594092 |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2017-05-26 |
| 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 | 0 |
| Brand Name | HUDSON ADAPTOR,CUFF,22MM ID |
| Generic Name | CONNECTOR, AIRWAY |
| Product Code | BZA |
| Date Received | 2017-05-26 |
| Returned To Mfg | 2017-08-04 |
| Catalog Number | 1421 |
| Lot Number | 74C1700287 |
| 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 | 2017-05-26 |