MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; INTERMITTENT CATHETER

Catalog Number	010116
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2024
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.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the issue started with shipping a different catheter.The catheter color was different and made a little different.They started noticing irritation and some blood at times.They noticed the lighter colored ones caused the problem and it had a little larger hole.The hole was closer to the bend than to the darker colored ones.The patient uses 5 or 6 catheters a day, so they are aware of when there are changes.They noticed that the ones causing the problem were made in malaysia and the other was united states made but packaged in mexico.They would like to speak to someone about this issue and how best to solve it.Per customer via phone on 03jan2025, it was reported that the eyelet on the catheters manufactured in malaysia were larger and caused a little irritation.No medical intervention was reported.Per customer follow up on 04jan2025.Customer identified lot nghz2011, which were manufactured in malaysia, as the problematic lot that had a large eyelet and caused irritation.Customer also identified lot nght2414 as the product that was packaged in mexico, and in comparison, there were no issues.Customer requested that they only sent catheters that are united states product going forward.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received (2) photo samples.All photo samples showcase the case of bardem urological catheter.Visual evaluation of the returned sample noted two unopened (with original packaging), urological catheter.Visual inspection of the sample noted that one was made in malaysia and as they are different lot numbers which this can contribute to color difference.This met specification.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the issue started with shipping a different catheter.The catheter color was different and made a little different.They started noticing irritation and some blood at times.They noticed the lighter colored ones caused the problem and it had a little larger hole.The hole was closer to the bend than to the darker colored ones.The patient uses 5 or 6 catheters a day, so they are aware of when there are changes.They noticed that the ones causing the problem were made in malaysia and the other was united states made but packaged in mexico.They would like to speak to someone about this issue and how best to solve it.Per customer via phone on 03jan2025, it was reported that the eyelet on the catheters manufactured in malaysia were larger and caused a little irritation.No medical intervention was reported.Per customer follow up on 04jan2025.Customer identified lot nghz2011, which were manufactured in malaysia, as the problematic lot that had a large eyelet and caused irritation.Customer also identified lot nght2414 as the product that was packaged in mexico, and in comparison, there were no issues.Customer requested that they only sent catheters that are united states product going forward.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: INTERMITTENT 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21092198
• Report Number: 1018233-2025-00023
• Device Sequence Number: 15612544
• Product Code: KOD
• UDI-Device Identifier: 00801741029875
• UDI-Public: (01)00801741029875(11)240115(17)280531(10)NGHZ2011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: 010116
• Device Lot Number: NGHZ2011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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: Male