MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FOLEY TRAYS

Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
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 one of these foley catheter tray fell out and another the top broke.Per follow up via phone on (b)(6) 2023, it was reported that the customer pulled a catheter out of the box and the top was broken and liquid spilled out.Customer stated that they had been using the product for years and never had this issue.Customer also inquired about having the defective catheters being replaced.Customer was advised to contact liberator.
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 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.H3 other text: the device was not returned.
Event or Problem Description
It was reported that one of these foley catheter tray fell out and another the top broke.Per follow up via phone on 08aug2023, it was reported that the customer pulled a catheter out of the box and the top was broken and liquid spilled out.Customer stated that they had been using the product for years and never had this issue.Customer also inquired about having the defective catheters being replaced.Customer was advised to contact liberator.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be ¿inspection results (measurement, testing data) not verified by iqa assignee / error of inspector".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.
Event or Problem Description
It was reported that one of these foley catheter tray fell out and another the top broke.Per follow up via phone on 08aug2023, it was reported that the customer pulled a catheter out of the box and the top was broken and liquid spilled out.Customer stated that they had been using the product for years and never had this issue.Customer also inquired about having the defective catheters being replaced.Customer was advised to contact liberator.

• Brand Name: UNKNOWN FOLEY TRAYS
• Common Device Name: UNKNOWN FOLEY TRAYS
• 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: 17606681
• Report Number: 1018233-2023-06226
• Device Sequence Number: 15029608
• Product Code: EZL
• UDI-Device Identifier: 00801741019999
• UDI-Public: (01)00801741019999
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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: Lay User/Patient
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 10/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/01/2023; 10/26/2023
• 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