MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER

Model Number	0167L22
Medical Device Problem Codes	Illegible Information (4050); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
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 the irrigation port and the drainage port on the bard ribbed balloon 3-way continuous irrigation foley might not be adequately labelled.There were three ports on the distal end of the foley catheter.One port was clearly identifiable and was for the inflation and deflation of the balloon that holds the catheter in place in the bladder.The other two ports, one in the middle for drainage and one on the outside opposite the balloon inflation port for irrigation were not clearly identified on the catheter itself.The potential existed for a healthcare provider to mix up the ports and connect the irrigation bag to the drainage port and the drainage bag to the irrigation port.This could potentially cause patient harm as the bladder would not be adequately irrigated and drained.
Additional Manufacturer Narrative
The reported event is unconfirmed.As the memo attached states, "in determining requirements for instructions for use, prescription devices, was consulted as appropriate reference since this device is rx only ¿ can be order only on the order / direction of a licensed physician that is medically trained in appropriate field of medicine.As determined by this assessment, this device may be exempted from instructions for use per the assessment provided in the table below and thus, additional labeling requirements are not needed".No root cause could be found because the reported event was unconfirmed.A dhr review was not required as the investigation was unconfirmed.Therefore, no additional action is required at this time.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The reported event is unconfirmed and a labeling review is not required.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 irrigation port and the drainage port on the bard ribbed balloon 3-way continuous irrigation foley might not be adequately labelled.There were three ports on the distal end of the foley catheter.One port was clearly identifiable and was for the inflation and deflation of the balloon that holds the catheter in place in the bladder.The other two ports, one in the middle for drainage and one on the outside opposite the balloon inflation port for irrigation were not clearly identified on the catheter itself.The potential existed for a healthcare provider to mix up the ports and connect the irrigation bag to the drainage port and the drainage bag to the irrigation port.This could potentially cause patient harm as the bladder would not be adequately irrigated and drained.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12170337
• Report Number: 1018233-2021-04214
• Device Sequence Number: 4581406
• Product Code: KOD
• UDI-Device Identifier: 00801741018978
• UDI-Public: (01)00801741018978
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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 Model Number: 0167L22
• Device Catalogue Number: 0167L22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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