MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-11 for BARD FEMALE CATH KIT 0035720 manufactured by C.r. Bard, Inc..
[17392616]
It was reported that there was difficulty in visualizing the urethra of a female pt on whom they obtained urine with a straight catheter. The physician ordered a temperature foley catheter. The nurse used the straight catheter as a guide, inserting the temperature foley catheter above the straight catheter tube. The straight catheter passed into the pt's bladder and could not be retrieved by the rn. Urology was consulted and a bedside flexible cystoscopy was performed to retrieve the straight catheter without any difficulty. The pt tolerated the procedure well and required no additional studies.
Patient Sequence No: 1, Text Type: D, B5
[17656316]
The sample was discarded. The lot number was not provided, therefore, the device history record could not be reviewed. There is nothing in the manufacturing process that could have caused or contributed to the reported failure. The instructions for use for obtaining specimens states, "pull catheter out of tube to desired length. Lay tube on sterile field. Proceed with catheterization. Pull catheter out of top; tighten cover and depress blue spout. " this is a user-related event. The user facility confirms that the device was used off-label and is the cause of the event. Bard has contacted the (b)(4) on (b)(6) 2011 regarding this incident. (b)(4) has stated that she will be conducting a facility-wide retraining on the off-label use of devices. We will continue to monitor the field performance of this product to identify any emerging trends. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2011-00042 |
| MDR Report Key | 2018918 |
| Report Source | 05 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-02-10 |
| Date of Event | 2011-01-31 |
| Date Mfgr Received | 2011-02-10 |
| Date Added to Maude | 2011-03-17 |
| 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 | NYCOLE SAYER |
| Manufacturer Street | 8195 INDUST BOULEVARD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846969 |
| Manufacturer G1 | BARD MEDICAL |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD FEMALE CATH KIT |
| Product Code | FFH |
| Date Received | 2011-03-11 |
| Model Number | NA |
| Catalog Number | 0035720 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-11 |