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 2018-08-29 for PORTEX? SELDINGER CHEST DRAINAGE KIT 200/910/120 manufactured by Smiths Medical Asd; Inc..
[118615734]
Patient Sequence No: 1, Text Type: N, H10
[118615735]
Information was received indicating that an air fistula was detected leading to leaking of the smiths medical portex? Seldinger chest drainage system. The drain was removed as the leak was unable to be found. Upon visual examination of the drain, a 1 cm long longitudinal crack was noted at the screw attachment of the drain. It was reported that the drainage system was not removing cerebral spinal fluid (csf) as it was supposed to but after the system change out, 100mls of csf drained. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-03568 |
| MDR Report Key | 7828393 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-08-29 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? SELDINGER CHEST DRAINAGE KIT |
| Generic Name | THORACIC CATHETER INSERTION TRAY |
| Product Code | PYI |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2018-08-29 |
| Catalog Number | 200/910/120 |
| Lot Number | 3566212 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-08-29 |