MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CLOSED SYSTEM URINARY DRAINAGE BAG; DRAIN BAG

Model Number	N153509
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 drain bag had extreme kinking in the tubing making it unusable.
Additional Manufacturer Narrative
The reported event was confirmed.The device had not met specifications.The product was intended to be used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging except white sheet), drainage tubing and the outlet tubing area of a drain bag.Visual inspection of the sample noted that the drainage tubing appeared visibly kinked (>>50% tubing diameter reduction).Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿incorrect assembly operation / components placement / accessories.(incorrect assembly).¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.This product is a bard center entry closed system urinary drainage bag and is sold as single use, non-sterile bulk pack (n=40) with appropriate labeling identification and revision data as well as manufacturer contact information.The case box also identifies the product as not containing latex.The product is designated as prescription only (rx only).Thus, in determining requirements for adequate instructions for use, prescription devices was consulted as appropriate reference.As determined by this assessment, this device may be exempted from instructions for use per the assessment.Corrections: d10, h3.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.
Event or Problem Description
It was reported that the drain bag had extreme kinking in the tubing making it unusable.

• Brand Name: BARD CLOSED SYSTEM URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10122247
• Report Number: 1018233-2020-03576
• Device Sequence Number: 2094677
• Product Code: KNX
• UDI-Device Identifier: 10801741046770
• UDI-Public: (01)10801741046770
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: Other
• Device Expiration Date: 02/28/2025
• Device Model Number: N153509
• Device Catalogue Number: N153509
• Device Lot Number: NGEP0822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1