MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX EXTENSION TUBING - STERILE; EXTENSION TUBING WITH CONNECTOR

Catalog Number	6A4194
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the extension tubing tends to bend and as a result urine backs up.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿bended tube¿ with a potential root cause of "incorrect assembly operation of tube coiling (incorrect assembly)" the lot number is unknown therefore the device history record could not be reviewed.This product is part of the devices that are commonly known to physicians for rx exemptions for having adequate direction for use as per 21 cfr subpart d section 801.109 (c), referencing: ¿provided, however, that such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device.Upon written request, stating reasonable grounds therefor, the commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso¿.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 device was not returned.
Event or Problem Description
It was reported that the extension tubing tends to bend and as a result urine backs up.No medical intervention was reported.

• Brand Name: LATEX EXTENSION TUBING - STERILE
• Common Device Name: EXTENSION TUBING WITH CONNECTOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8898954
• Report Number: 1018233-2019-04780
• Device Sequence Number: 16581058
• Product Code: KNX
• UDI-Device Identifier: 00801741051579
• UDI-Public: (01)00801741051579
• 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: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 6A4194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1