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

Model Number 33616

Device Problems Component Misassembled (4004); Missing Information (4053)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that a piece of the foley catheter arrived incomplete because it lacked the identification color.

Event Description

It was reported that a piece of the foley catheter arrived incomplete because it lacked the identification color.

Manufacturer Narrative

The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment the product caused the reported failure.Visual evaluation of the returned sample noted one unopened (within original packaging), unused silastic foley.Visual inspection of the sample noted that the inflation cap was missing.This does not meet the specification "the cap must be present, the height and position must be correct." a potential root cause for this failure could be operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.The actual/suspected device was evaluated.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment the product caused the reported failure.Visual evaluation of the returned sample noted one unopened (within original packaging), unused silastic foley.Visual inspection of the sample noted that the inflation cap was missing.This does not meet the specification as "the cap must be present, the height and position must be correct.".A potential root cause for this failure could be operator error.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 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 actual/suspected device was inspected.

Event Description

It was reported that a piece of the foley catheter arrived incomplete because it lacked the identification color.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11820057
• MDR Text Key: 250463805
• Report Number: 1018233-2021-02763
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020063
• UDI-Public: (01)00801741020063
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 33616
• Device Catalogue Number: 33616
• Device Lot Number: NGEW1836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other