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 2017-09-07 for ADAPTOR,CUFF,22MM ID 1421 manufactured by Teleflex Medical.
[85130554]
(b)(4). Visual inspection of the product involved in the complaint was performed on the returned sample. It is noted that the product was not received in its original packaging. It can be observed a damage issue on the adaptor. No other issues were found. A device history record review showed that there were no issues related to the reported failure mode, neither on the product nor its components, during the manufacture of this material. Customer complaint is confirmed based on sample provided. However, there is not sufficient evidence to determine this issue originated during manufacturing process. The root cause for the condition reported could not be identified. No corrective actions can be assigned. A conclusion code could not be assigned. The complaint is confirmed but the root cause could not be identified. Teleflex will continue to monitor and trend for reports of this issue.
Patient Sequence No: 1, Text Type: N, H10
[85130555]
Customer complaint alleges they "are having issues with carefusion or teleflex products depositing shards of plastic in the circuits. " alleged defect noted during use. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00336 |
| MDR Report Key | 6848466 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-07 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-09-07 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 | ADAPTOR,CUFF,22MM ID |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-09-07 |
| Returned To Mfg | 2017-08-04 |
| Catalog Number | 1421 |
| Lot Number | 74M1602188 |
| 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 | 2017-09-07 |