MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-07 for PORTEX GENERAL ANESTHESIA CIRCUIT C45101340-NLJ manufactured by Smiths Medical Asd, Inc..
[138159211]
Lot number: lot contains the following possible numbers: 180528. (b)(6). Device evaluation: one breathing circuit was received for investigation. The sample was received in used condition without its original packaging. Immediate visual inspection detected a hole in the product. A leak functional test was completed and the device did not pass. In addition, leak tests were audited in order to verify that all components were free of damage or defects. Thirty two (32) units were reviewed and no discrepancies were found. A review of the manufacturing process was also conducted and was considered adequate and correct. Based on the evidence and testing, the complaint allegation was confirmed. The root cause was listed as unknown.
Patient Sequence No: 1, Text Type: N, H10
[138159212]
Information was received that a smiths medical portex general anesthesia circuit had a small pinhole leak while in use. The issue was discovered after hearing an air leak sound and it was reported they were able to cover the pinhole with tape. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01275 |
| MDR Report Key | 8401517 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-03-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD, HYTHE KENT CT21 6JL |
| Manufacturer City | KENT, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX GENERAL ANESTHESIA CIRCUIT |
| Generic Name | CIRCULATOR, BREATHING-CIRCUIT |
| Product Code | CAG |
| Date Received | 2019-03-07 |
| Returned To Mfg | 2019-02-26 |
| Catalog Number | C45101340-NLJ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |