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

Device Problems Inaccurate Flow Rate (1249); Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

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 Description

It was reported that the patient was experiencing backflow while using the bard foley catheter that was received from the hospital.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be operator¿s error- missed plug the catheters into the spigot on the manifold and cause occluded drainage eye (reduced flow rate).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 for this device is unknown, the foley catheter ifus are found to be adequate based on past reviews.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 device was not returned.

Event Description

It was reported that the patient was experiencing backflow while using the bard foley catheter that was received from the hospital.

Manufacturer Narrative

Per additional information received, it has been determined that this mdr event is not reportable.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 Description

It was reported that the patient was experiencing backflow while using the bard foley catheter that was received from the hospital.Per follow up on 06aug2021, stated the issue was that patient did not receive the correct catheters.Per clarification mail on 09aug2021, patient did not have a backflow issue and the only issue was received the wrong products in shipment and had issues getting it resolved with liberator.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12130831
• MDR Text Key: 260360097
• Report Number: 1018233-2021-04086
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other