MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO DRAINAGE VALVE

Model Number	150419
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
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.
Event or Problem Description
It was reported that the bag was wrinkled, and the urination valve was attached at an angle.Per follow-up information received from ibc on 18-jan-2023, stated that no urine was able to be drained.Per follow-up information received from ibc on 24-jan-2023, stated that the complaint was about the bag being wrinkled and the urinary drainage cock being at an angle, with no mention of urine flow.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Visual evaluation noted received 1 dispoz-a-bag.The product was used for patient diagostic or treatment.The product was not influenced by the reported event.Dhr review is not required as the reported event is unconfirmed.Labeling review is not required as the reported event is unconfirmed.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.H3 other text: the actual/suspected device was evaluated.
Event or Problem Description
It was reported that the bag was wrinkled and the urination valve was attached at an angle.Per follow-up information received from ibc on 18jan2023, stated that no urine was able to be drained.Per follow-up information received from ibc on 24jan2023, stated that the complaint was about the bag being wrinkled and the urinary drainage cock being at an angle, with no mention of urine flow.

• Brand Name: LEG BAG WITH FLIP-FLO DRAINAGE VALVE
• Common Device Name: LEG 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: 16282793
• Report Number: 1018233-2023-00543
• Device Sequence Number: 4880778
• Product Code: FAQ
• UDI-Device Identifier: 00801741080654
• UDI-Public: (01)00801741080654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: Health Professional
• Device Model Number: 150419
• Device Catalogue Number: 150419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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