MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD ELLIK BLADDER EVACUATOR MEDIUM WALL RED RUBBER BULB ONLY, 3 OZ. NON-STERILE; NON-DISPOSABLE ELLIK BLADDER EVACUATOR

Catalog Number	004501
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the rubber bulb on the reusable ellik evacuator degrades over time.It was noted that the reusable ellik evacuators were sterilized using an autoclave.
Event or Problem Description
It was reported that the rubber bulb on the reusable ellik evacuator degrades over time.It was noted that the reusable ellik evacuators were sterilized using an autoclave.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "contents one unit caution: this product contains natural rubber latex which may cause allergic reactions.Bard® ellik bladder evacuator caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Caution: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.Bard c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 packaged in mexico pi-50485 5/99".

• Brand Name: BARD ELLIK BLADDER EVACUATOR MEDIUM WALL RED RUBBER BULB ONLY, 3 OZ. NON-STERILE
• Common Device Name: NON-DISPOSABLE ELLIK BLADDER EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7591970
• Report Number: 1018233-2018-02203
• Device Sequence Number: 217882
• Product Code: KQT
• UDI-Device Identifier: 00801741049057
• UDI-Public: (01)00801741049057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 004501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1