MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for EQUASHIELD FEMALE LL CONNECTOR FC-1S manufactured by Equashield Llc.
[185928942]
Closed system connector attached to chemotherapy infusion has leaked on 4 separate occasions, leaking chemotherapy. The product has recently changed (previous ref (b)(4) and we have had not problems with the previous product. It is leaking at the "collar" right where the product screws into the tubing. Equashield (b)(4): (b)(6) 2020 - (b)(6) 2020. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093971 |
| MDR Report Key | 9902700 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-25 |
| Date Added to Maude | 2020-03-31 |
| 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 | PHARMACIST |
| 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 | EQUASHIELD FEMALE LL CONNECTOR FC-1S |
| Generic Name | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Product Code | ONB |
| Date Received | 2020-03-30 |
| Model Number | FC-1S |
| Catalog Number | FC-1S |
| Lot Number | 200590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EQUASHIELD LLC |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |