MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER

Model Number	0102SI16
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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.
Event or Problem Description
It was reported that while inserting the foley catheter into the patient that the catheter cracked, the balloon deflated and then the catheter fell out of the patient.Per follow up received on (b)(6) 2021, the catheter was cracked on the shaft and there was no patient impact or missing pieces.
Event or Problem Description
It was reported that while inserting the foley catheter into the patient that the catheter cracked, the balloon deflated and then the catheter fell out of the patient.Per follow up received on 08jun2021, the catheter was cracked on the shaft and there was no patient impact or missing pieces.
Additional 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 had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), red two-way silicone foley catheter.Visual inspection of the sample noted a clean slice on the shaft of the catheter.The catheter has a bagger machine cut, which is the root cause of the deflation issue.This device is considered out of specification.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 labeling could not have prevented the reported failure.The actual/suspected device was inspected.

• Brand Name: BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12085206
• Report Number: 1018233-2021-03888
• Device Sequence Number: 3870838
• Product Code: MJC
• UDI-Device Identifier: 00801741017070
• UDI-Public: (01)00801741017070
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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
• Report Date (Section B): 02/10/2022

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: 10/31/2024
• Device Model Number: 0102SI16
• Device Catalogue Number: 0102SI16
• Device Lot Number: NGEW2411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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