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

Model Number	1758SI14
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
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.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 customer had an issue on (b)(6) with a foley catheter that was missing the bottom connecter that let them drain it.Instead, it just had a hole where it should be leaving the bag open to air.They had to open a second kit to get the clamp out of it.Per follow up via email received on 11jul2023, no sample available.The foley was discarded upon discovering the issue as it had touched the patient.The patient status was discharged.The situation was fixed immediately from placement as they realized the bag was open when hanging it.The product was nonfunctional as there was a hole in the collection bag where the emptying spout should have been.Customer then had to open another kit to replace the bag so there was not any spilling.
Event or Problem Description
It was reported that the customer had an issue on (b)(6) with a foley catheter that was missing the bottom connecter that let them drain it.Instead, it just had a hole where it should be leaving the bag open to air.They had to open a second kit to get the clamp out of it.Per follow up via email received on (b)(6) 2023, no sample available.The foley was discarded upon discovering the issue as it had touched the patient.The patient status was discharged.The situation was fixed immediately from placement as they realized the bag was open when hanging it.The product was nonfunctional as there was a hole in the collection bag where the emptying spout should have been.Customer then had to open another kit to replace the bag so there was not any spilling.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be" not trained personnel in assembly operation: outlet tube / tube holder connector".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling 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.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG
• 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: 17342628
• Report Number: 1018233-2023-05250
• Device Sequence Number: 12474934
• Product Code: KNX
• UDI-Device Identifier: 00801741029554
• UDI-Public: (01)00801741029554
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 1758SI14
• Device Catalogue Number: 154004A
• Device Lot Number: NGGV2783
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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