MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-07 for BARD? ELLIK EVACUATOR 000451 manufactured by C.r. Bard, Inc. (covington) -1018233.
[99886997]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "bard? Ellik evacuator caution: this product contains natural rubber latex which may cause allergic reactions. Fill with solution. Displace all air before using. This is a single use device. Do not resterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. Note: for use with resectoscope sheath manufactured by (b)(4). A separate adapter is enclosed for use with resectoscope sheath manufactured by acmi. Single use do not resterilize caution, consult accompanying documents. Contains or presence of natural rubber latex. Do not use if package is damaged. Units sterilized using ethylene oxide authorized representative in the european community use by catalog number lot number manufacturer caution: federal (usa) law restricts this device to sale by or on the order of a physician. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations. Bard is a trademark and/or registered trademark of c. R. Bard, inc. Manufactured in (b)(4). " the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[99886998]
It was reported that the device leaked when it was connected to the scope. The user had to open four devices to find one that would not leak. It was later reported that the water used to rinse the bladder out was leaking out of the connection. The procedure was a turp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00376 |
| MDR Report Key | 7247252 |
| Date Received | 2018-02-07 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2017-03-24 |
| Date Added to Maude | 2018-02-07 |
| 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 | AMY GRAVLEY |
| 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 | 0 |
| Brand Name | BARD? ELLIK EVACUATOR |
| Generic Name | ELLIK EVACUATOR |
| Product Code | KQT |
| Date Received | 2018-02-07 |
| Model Number | 000451 |
| Catalog Number | 000451 |
| Lot Number | NGBP4425 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-02-07 |