MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-07 for ANGIO-CATH PACK CXDP36H manufactured by American Contract System.
[99607054]
Product contamination - unidentified hair found in sterile catheterization packet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075121 |
| MDR Report Key | 7251011 |
| Date Received | 2018-02-07 |
| Date of Report | 2018-02-06 |
| Date of Event | 2018-02-06 |
| Date Added to Maude | 2018-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANGIO-CATH PACK |
| Generic Name | ANGIO-CATH PACK |
| Product Code | OEQ |
| Date Received | 2018-02-07 |
| Model Number | CXDP36H |
| Lot Number | 665171 |
| Device Expiration Date | 2018-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEM |
| Manufacturer Address | MN 55437 US 55437 |
| Brand Name | ANGIO-CATH PACK |
| Generic Name | ANGIO-CATH PACK |
| Product Code | OEQ |
| Date Received | 2018-02-07 |
| Model Number | CXDP36H |
| Lot Number | 665171 |
| Device Expiration Date | 2018-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEM |
| Manufacturer Address | MINNEAPOLIS MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-07 |