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

Catalog Number	004501
Medical Device Problem Code	Naturally Worn (2988)
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 device was not returned.
Event or Problem Description
It was reported that there was debris exiting from the bulb.Per additional information received via email on 23 april 2020 from a bd associate, the customer had been using the product for 5 years and the bulb that is made of rubber peeled.This was an overuse of the product.
Event or Problem Description
It was reported that there was debris exiting from the bulb.Per additional information received via email on 23 april 2020 from a bd associate, the customer had been using the product for 5 years and the bulb that is made of rubber peeled.This was an overuse of the product.
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 were found adequate and state the following: ¿contents: one unit 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.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 packaged in mexico pi-50485 5/99 caution: this product contains natural rubber latex which may cause allergic reactions.Released." h11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARD ELLIK BLADDER EVACUATOR MEDIUM WALL RED RUBBER BULB ONLY, 3 OZ.,
• Common Device Name: ELIK EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10059012
• Report Number: 1018233-2020-03217
• Device Sequence Number: 2628844
• Product Code: KQT
• UDI-Device Identifier: 00801741049057
• UDI-Public: (01)00801741049057
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1