MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK BLADDER EVACUATOR

Catalog Number	0450M
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
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.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the customer ordered 4 ellik bladder evacuator, 1 arrived damaged, box was not damaged.The product inside of box itself was damaged.Also stated that there were 2 tubes poking out a big one and little one.They noticed it was broken out at the end of tube.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation and further investigation was not conclusive.A potential root cause for this event could be, "inappropriate package design".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Fill with water and attach to sheath.2.Flow water in and out of bladder creating a whirling action of water in the trap.3.Trap tissue pieces in bottom portion of hourglass-shaped trap.This ellik evacuator is for evacuating tissue segments during transurethral prostatic resection.The metal connection will fit the stern-mccarthy resectoscope." h11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the customer ordered 4 ellik bladder evacuator, 1 arrived damaged, box was not damaged.The product inside of box itself was damaged.Also stated that there were 2 tubes poking out a big one and little one.They noticed it was broken out at the end of tube.

• Brand Name: BARD® ELLIK BLADDER EVACUATOR
• Common Device Name: BLADDER EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17620728
• Report Number: 1018233-2023-06306
• Device Sequence Number: 6154255
• Product Code: KQT
• UDI-Device Identifier: 00801741080807
• UDI-Public: (01)00801741080807
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 0450M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown