MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

Model Number	802520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
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 the patient had been using the intermittent catheters since 1980 and noticed an issue on and off for years.Customer stated that the issue was it seemed all the red rubber intermittent catheters were not the same size although it stated it was on the package and how they knew was that the tips were obviously different in size and it affected the results during usage.Stated that if the tip was smaller the customer was successful and if it was larger or fuller the customer was not.Per customer via email on (b)(6) 2022, it was stated that in a package of 15 intermittent catheters, the majority of the catheters were too big.The customer provided two lot numbers (batch#: nggn0626 material#: 802520 ; batch#: ngep1662 material#: 802520).The customer stated that this had been going on for a few years.Per investigator notification on (b)(6) 2022, it was reported that an unopened intermittent catheter sent for sample evaluation was noted to be twisted when returned.
Event or Problem Description
It was reported that the patient had been using the intermittent catheters since 1980 and noticed an issue on and off for years.Customer stated that the issue was it seemed all the red rubber intermittent catheters were not the same size although it stated it was on the package and how they knew was that the tips were obviously different in size and it affected the results during usage.Stated that if the tip was smaller the customer was successful and if it was larger or fuller the customer was not.Per customer via email on 24aug2022, it was stated that in a package of 15 intermittent catheters, the majority of the catheters were too big.The customer provided two lot numbers (batch# nggn0626 material# 802520 ; batch# ngep1662 material# 802520).The customer stated that this had been going on for a few years.Per investigator notification on 12oct2022, it was reported that an unopened intermittent catheter sent for sample evaluation was noted to be twisted when returned per notification from investigator based on sample evaluation on 09feb2023, it was found that the sticky residue was present on the surface of the intermittent catheter.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Three coude olive tip catheters were returned unopened.The catheters were noted to be smooth.Catheter 1 - the coude tip did not appear to be aligned with coude indicator notch when the catheter was removed from the packaging and laid flat, the catheter was then secured with tape to remain flat and the tip and coude indicator notch were noted be be aligned.Catheter 2 - the coude tip was noted to align with the coude indicator notch when the catheter was removed from the packaging and laid flat.Catheter 3 - the coude tip was noted to align with the coude indicator notch when the catheter was removed from the packaging and laid flat.Using a french gauge all three catheters were confirmed to be 22fr., which is out of specifications which states, "accept if french size measures within +/- 1 french size." although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "inappropriate package design".The device was not used for patient treatment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." 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 actual/suspected device was inspected.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15649865
• Report Number: 1018233-2022-08048
• Device Sequence Number: 2381403
• Product Code: KOD
• UDI-Device Identifier: 00801741039072
• UDI-Public: (01)00801741039072
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 09/30/2026
• Device Model Number: 802520
• Device Catalogue Number: 802520
• Device Lot Number: NGGN0626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2022
• 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