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

Model Number	N153509
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 which made it unusable.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual inspection noted 3 boxes of 40 center entry bags each were received.Visual evaluation noted the box packaging had exterior damage to it and had evidence of opening and resealing.Samples were tested.The box was opened and the devices were all of random orientation giving supporting evidence that the packages were previously opened and replaced back into the box.Two of the samples evaluated had drain bags with their inlet tubing kinked right above the entry into the bag.This fails to meet specifications as "any kinks in drainage tube which reduce the inner diameter more than 25% are 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.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.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 which made 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: 10405045
• Report Number: 1018233-2020-05181
• Device Sequence Number: 2801236
• 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): 11/23/2020

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: 10/31/2024
• Device Model Number: N153509
• Device Catalogue Number: N153509
• Device Lot Number: NGDX4526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1