MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EXTENSION TUBE, 5/16" I.D. X 18" WITH CONNECTOR

Catalog Number	4A4194
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect assembly operation (incorrect assembly).The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because instruction for use could not have prevented the reported failure.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the extension tubing customer received was curled and would not stay straight.It did not allow the urine to drain in the night because it would not stay straight.Customer also stated they used to receive the straight extension tubing but now received the curled one and it was not working for them.Per customer via phone on 07sep2023, it was reported that the patient was receiving their medical supplies from (b)(4).The customer had received the extension tube from them for the last nine years, but over the last two years, they had received them curled.It arrived warped and not in a u-shape.No matter how many times they straightens the tube, it would not hold shape.This caused them drain bag to bend at night.When in public, they had several occurrences with the tube protruding near their thigh and pelvic area, caused considerably discomfort.The customer felt this was a manufacturing error, and they would reach out to his vendor for a substitute or alternative as needed.They was merely inquiring as to what bd currently had in their inventory.Once this information has been added to the complaint, no additional information is available, and no physical sample is available.

• Brand Name: EXTENSION TUBE, 5/16" I.D. X 18" WITH CONNECTOR
• Common Device Name: EXTENSION TUBE, 5/16" I.D. X 18" WITH CONNECTOR
• 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: 17780089
• Report Number: 1018233-2023-06901
• Device Sequence Number: 6576302
• Product Code: FAQ
• UDI-Device Identifier: 00801741051562
• UDI-Public: (01)00801741051562
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/06/2023

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 Catalogue Number: 4A4194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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