MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FOLEY TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER

Model Number	861014
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
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 while attempting to inflate the foley catheter, the cap of the syringe was missing and the syringe was dry.The sterile outer package was completely intact with no evidence that it had ever been opened.It was also reported that there was no cap on the luer tip.The catheter could not be used and was discarded.Per follow up via mail on 22apr2021, customer had one kit defect and had two others unopened yet.The cap on the luer tip was missing and syringe was dry inside.
Additional Manufacturer Narrative
The reported event was inconclusive.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 ¿.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review is not required because a review of the label could not have prevented this issue.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 while attempting to inflate the foley catheter, the cap of the syringe was missing and the syringe was dry.The sterile outer package was completely intact with no evidence that it had ever been opened.It was also reported that there was no cap on the luer tip.The catheter could not be used and was discarded.Per follow up via mail on (b)(6) 2021, customer had one kit defect and had two others unopened yet.The cap on the luer tip was missing and syringe was dry inside.

• Brand Name: BARD FOLEY TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11715897
• Report Number: 1018233-2021-02337
• Device Sequence Number: 4244877
• Product Code: EZC
• UDI-Device Identifier: 00801741040382
• UDI-Public: (01)00801741040382
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2021

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: Lay User/Patient
• Device Expiration Date: 03/15/2020
• Device Model Number: 861014
• Device Catalogue Number: 861014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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