MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-09-05 for SKATER SINGLE STEP 756006025E manufactured by Argon Medical Devices Inc..
[4739340]
Pt had residual empyema. Pigtail catheter placed. After catheter placement, a whistling sound is heard. A small hole by the hub into the lumen is found. Air is sucked into the closed circuit causing a pneumothorax to the pt. End user believes a catheter meant for a string has been packed by mistake. Pt developed pneumothorax and eminently a new drain was placed. Pt did not have symptoms of the pneumothorax. End user believes if the pt had been more "lung sick" the incident could potentially have had serious consequences.
Patient Sequence No: 1, Text Type: D, B5
[12225954]
The complaint product was manufactured by (b)(4) which was purchased by argon medical devices, inc. An image was provided and it was confirmed that a drilled hole was on the non-string skater catheter hub. The drilled hole in the non-strung skater catheter hub is not a requirement. Review of the lower-level device history record showed that the operator had originally thought there was a drilling operation for the non-strung catheter. The operator corrected the job order at the start of manufacture. It is possible that a hub drilled unit may have been placed into the bin with the undrilled units and continued on with the catheter marking operation as required from the router. The upper level job orders do not have any rejections for the hub being drilled and they have passed the 100% qc visual inspections. It should be obvious there is a hole in the hub where there should not be one. The label picture does not show the hub with a hole and no mention of the hole is in the ifu. Three (3) retain samples for part 7560ma16025 lot fn9f were reviewed by visual inspection and did not contain a drilled hole in the hub. No further/related issues were found for the finish product lots.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2014-00027 |
| MDR Report Key | 4071260 |
| Report Source | 05,08 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2014-08-06 |
| Device Manufacturer Date | 2013-09-04 |
| Date Added to Maude | 2014-09-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK RD. |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 9722102562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER SINGLE STEP |
| Generic Name | SKATER |
| Product Code | GBQ |
| Date Received | 2014-09-05 |
| Model Number | 756006025E |
| Lot Number | 32772KDI |
| Device Expiration Date | 2018-09-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | ATHENS TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-05 |