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

Model Number 150419

Device Problem Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 308727591
• Report Number: 1018233-2023-00543
• Device Sequence Number: 1
• Product Code: FAQ
• UDI-Device Identifier: 00801741080654
• UDI-Public: (01)00801741080654
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other