MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; DRAIN BAG

Model Number	A902916
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
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 customer had multiple complaints about the surestep foley tray system that they had in stock.Stated that the main concern was foley bag not draining effectively and the nurses have to put the bag on the floor in order to get it to drain.It was stated that this was a concern when doing surgery as the provider were finding full bladders possible leading to one injury so far.While putting the bag on the floor was helping, it was absolutely against all infection control standards.
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 bard 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 bard.
Event or Problem Description
It was reported that the customer had multiple complaints about the surestep foley tray system that they had in stock.Stated that the main concern was foley bag not draining effectively and the nurses have to put the bag on the floor in order to get it to drain.It was stated that this was a concern when doing surgery as the provider were finding full bladders possible leading to one injury so far.While putting the bag on the floor was helping, it was absolutely against all infection control standards.
Event or Problem Description
It was reported that the customer had multiple complaints about the surestep foley tray system that they had in stock.Stated that the main concern was foley bag not draining effectively and the nurses have to put the bag on the floor in order to get it to drain.It was stated that this was a concern when doing surgery as the provider were finding full bladders possible leading to one injury so far.While putting the bag on the floor was helping, it was absolutely against all infection control standards.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "static/ positive air pressure".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.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.

• Brand Name: URINE COLLECTION
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14135657
• Report Number: 1018233-2022-02621
• Device Sequence Number: 5555638
• Product Code: KNX
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/07/2022
• 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: 11/30/2023
• Device Model Number: A902916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 07/07/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 06/01/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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