MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Model Number	802001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had urinary tract infection that was permanent.Patient spoke previously with another representative who asked about a particular drain bag and could not provide this since it was produced by a competitor.It was noted that the patient could switch over to another supplier who carried them and wanted to continue ordered same supplies.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.
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 patient had urinary tract infection that was permanent.Patient previously spoke with another representative and asked about a particular drain bag and the representative could not provide it since it was produced by a competitor.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to ¿materials of construction are not biocompatible¿.It is 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 dhr review could not be performed without a lot number.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: 1.Wash hands.2.Remove protective cap from drainage tube and connect drainage tube adapter to catheter.3.Fasten drainage bag to bedframe near the foot of the bed.Do not allow bag to touch floor.Important: hang drainage tube in a straight fashion from bedside to drainage bag.If drainage bag is placed even with patient¿s hip, coil tubing alongside patient.Tubing should be draped over patient¿s leg.4.Check that urine is draining into bag.5.To empty bag: a.Remove outlet tube from housing.B.Release clamp and empty bag.C.When bag is empty, return clamp to closed position and replace tube in housing.Note: if specimen is required, see directions for obtaining urine sample.6.Wash hands.7.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Directions for obtaining urine sample: 1.Kink tubing a minimum of 3 inches below sample sleeve until urine is under sample site.2.Swab surface of puncture site with antiseptic wipe.3.Insert needle (21g or smaller) through center of puncture site.Be careful to avoid puncturing opposite side of sample sleeve.4.Remove desired volume of urine.Release kink to permit flow to drainage bag.5.Send specimen to laboratory" 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 device was not returned.

• Brand Name: BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: URINARY DRAINAGE 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: 16589962
• Report Number: 1018233-2023-01928
• Device Sequence Number: 2907376
• Product Code: KNX
• UDI-Device Identifier: 00801741040740
• UDI-Public: (01)00801741040740
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 802001
• Device Catalogue Number: 802001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/08/2023
• 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