MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2017-11-08 for PORTEX? SELDINGER CHEST DRAINAGE KIT manufactured by Smiths Medical Asd, Inc..
[91381621]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[91381622]
Information was received indicating that upon removal of a smiths medical seldinger chest drainage drain the stiffening stylus was still intact. It was reported that the patient had the drain placed as treatment for a pneumothorax following tracheostomy (trach) placement. Subsequently, the patient's condition failed to improve and bilateral surgical chest drains were required to be implanted. The patient recovered with no adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
[109257135]
Patient Sequence No: 1, Text Type: N, H10
[109257136]
It was additionally reported that the patient had a tumour of the left hypopharynx and larynx, which was the suspected cause of the pneumothorax. The patient was admitted for feeding via an ng. The current status of the patient was stated as being the patient is currently being treated for other health related conditions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-02388 |
| MDR Report Key | 7011168 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-07-08 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-11-08 |
| 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 Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL NIJMEGEN |
| Manufacturer Street | BIJSTERHUIZEN 22 - 08 6604 LD |
| Manufacturer City | WIJCHEN, |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? SELDINGER CHEST DRAINAGE KIT |
| Generic Name | CHEST DRAINAGE KIT |
| Product Code | PAD |
| Date Received | 2017-11-08 |
| Device Availability | * |
| 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 NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-08 |