MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for MULTI-LUMEN CVC KIT manufactured by Arrow International, Inc..
[185223706]
Pt had a double lumen arrow central line in place with the second site adjustable hub and catheter clamp utilized to hold the line in place. When wet / damp / cleaned the central line easily moves out of the second site adjustable hub and catheter clamp. On this pt, the central line inadvertently fell out when it got wet despite the catheter clamp being sutured to the pt. This is the second pt this has occurred in and an add'l medwatch will be filed for that pt. Therapy date: (b)(6) 2020. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093924 |
| MDR Report Key | 9882760 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-16 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | MULTI-LUMEN CVC KIT |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| Lot Number | 13F19E0655 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |