MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for BARD FEMALE CATH KIT 0035720 manufactured by C.r. Bard, Inc..
[72094593]
Patient Sequence No: 1, Text Type: N, H10
[72094594]
Rn inserted catheter to perform a straight cath, was inserted without difficulty, but no urine was obtained. When pulling back to remove the catheter, it was unable to be removed/was stuck. Per palpation, the catheter was felt to be bent. Md was then called and he removed the catheter; and it was found to be bent approx. 1 inch from the tip. Per the md's notes: when nurse did urine catheter, the catheter coiled in the urethra and difficult to pull out. The nurse called me and i gently pulled it out and it came out as a whole, no break of the catheter seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6471508 |
| MDR Report Key | 6471508 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-02-12 |
| Report Date | 2017-03-24 |
| Date Reported to FDA | 2017-03-24 |
| Date Reported to Mfgr | 2017-03-24 |
| Date Added to Maude | 2017-04-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD FEMALE CATH KIT |
| Generic Name | COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER |
| Product Code | FFH |
| Date Received | 2017-04-07 |
| Catalog Number | 0035720 |
| Lot Number | NGAX1795 |
| ID Number | 8 FR |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |