MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for CATHETER, 28 FR RIGHT ANGLE 8128 manufactured by Atrium Medical.
[118747662]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[118747663]
Report received stated that a nurse was obtaining products from central supply stock for a case and found thoracic chest tube catheters that the packaging was unsealed on one end.
Patient Sequence No: 1, Text Type: D, B5
[121916807]
The thoracic catheter was received and inspected. The bottom side of the catheter pouch was found to be unsealed. Upon further inspection it was determined that there were no signs that the pouch had been attempted to be sealed. There were no witness lines created by the sealer or deformation of the film caused by the heat of the sealing process. The pvc thoracic catheters are supplied to atrium by a contract manufacturer ((b)(4)), which is responsible for the assembly and packaging processes. Atrium receives the product and performs an aql sampling and inspection of the packaged assembly. The inspection includes verification of appropriate labeling and packaging. Review of the receiving inspection records for this lot of catheters were found to have met specifications. Based on the confirmation of the complaint, atrium medical has issued a supplier corrective action request to the supplier of the catheters. Clinical evaluation: thoracic catheters are sterile, single use, disposable devices and are intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. A package that is unsealed would be expected to be noticed before it was entered into the sterile field, as it was in this case. It would represent a delay in treatment for the patient. The instructions for use (ifu) states do not use if the device or packaging is damaged.
Patient Sequence No: 1, Text Type: N, H10
[121916808]
N/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2018-00923 |
| MDR Report Key | 7818308 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2018-03-05 |
| Date Added to Maude | 2018-08-27 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CATHETER, 28 FR RIGHT ANGLE |
| Generic Name | CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 8128 |
| Catalog Number | 8128 |
| Lot Number | ME221275 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |