MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-12-21 for DAVOL? FEMALE CATH KIT 0035720 manufactured by C.r. Bard, Inc. (covington) -1018233.
[131162002]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[131162003]
It was reported that the gloves inside of the female catheter kit were sticking to each other, which resulted in one of the gloves falling out of the tray onto a non-sterile surface. The complainant reported that the issue could be contributing to catheter associated infections. Per follow up with the complainant by phone on (b)(6) 2018 it was noted that utis were diagnosed but there was no information available on the specific treatment provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-06109 |
| MDR Report Key | 8189522 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-12-21 |
| Date of Report | 2019-02-04 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-08-04 |
| Date Added to Maude | 2018-12-21 |
| 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 Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVOL? FEMALE CATH KIT |
| Generic Name | FEMALE CATHETER KIT |
| Product Code | FFH |
| Date Received | 2018-12-21 |
| Catalog Number | 0035720 |
| Lot Number | NGCU3528 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |