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

Model Number	010118
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2021
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 the bard 18 fr urological catheters were twisted and the guiding nib did not line up with the coude tip.It was stated that it was difficult to ensure the catheter tip was pointing up and there were 17 catheters from a 10 box order.The patient experienced pain and bleeding.No medical intervention was reported.
Event or Problem Description
It was reported that the bard 18 fr urological catheters were twisted and the guiding nib did not line up with the coude tip.It was stated that it was difficult to ensure the catheter tip was pointing up and there were 17 catheters from a 10 box order.The patient experienced pain and bleeding.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.One samples was confirmed to exhibit the reported failure.An orange coude tip catheter was returned unopened in original packaging.The coude tip appeared to be misaligned with the coude indicator.The catheter was straightened and taped down.The tip was still misaligned with the indicator.A potential root cause for this failure could be "machine error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is confirmed manufacturing related.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.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE 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: 11778722
• Report Number: 1018233-2021-02603
• Device Sequence Number: 3647251
• Product Code: KOD
• UDI-Device Identifier: 00801741029882
• UDI-Public: (01)00801741029882
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 010118
• Device Catalogue Number: 010118
• Device Lot Number: NGEV3232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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