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

Model Number	000451
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
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.
Event or Problem Description
It was reported that a large plastic chip was present in the ellik pear when it was opened from the bag.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), unused ellik evacuator with tape over the end of the rubber tubing.Visual inspection of the sample noted that there was a hard piece of plastic stuck in the inside of the rubber tubing.The foreign material was much larger than 0.6 sq mm.This does not meet the specification as "loose or embedded foreign matter shall not exceed an aggregate total of 0.6mm² or 1/16" in length ".A potential root cause for this failure could be due to "defective components of supplier / with contamination".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labelling could not have prevented the reported failure.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that a large plastic chip was present in the ellik pear when it was opened from the bag.

• Brand Name: BARD ELLIK EVACUATOR
• Common Device Name: ELLIK BLADDER EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10909625
• Report Number: 1018233-2020-21225
• Device Sequence Number: 3045778
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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 Expiration Date: 12/31/2024
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGDZ3949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other