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.
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.Visual inspection noted 3 opened and unused center entry bags were received.Visual evaluation noted all 3 drain bags had their inlet tubes kinked right above the entry to the bag.This failed to meet specifications according to the standard which states any kink in drainage tube which reduces the id more than 25% is not permitted.Although the reported event was confirmed, a 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.The product is designated as prescription only (rx only).Thus, in determining requirements for adequate instructions for use, the standard on prescription devices was consulted as appropriate reference.As determined by this assessment, this device may be exempted from instructions for use per the assessment provided.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: 9975443
• Report Number: 1018233-2020-02676
• Device Sequence Number: 14412135
• 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): 06/07/2020

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: 12/31/2024
• Device Model Number: N153509
• Device Catalogue Number: N153509
• Device Lot Number: NGDZ3956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 06/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1