MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER WITH BAG

Model Number 153216

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/02/2023

Event Type  Injury  

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 Description

It was reported that the customer had a bard urine meter with bag and safety-flow outlet device which have multiple issues with these leaking.Per follow-up information received from ibc on (b)(6) 2023, stated that the problems had been occurring since they took delivery of these products.They don¿t have a batch number.The leak occurred on the second or third empty when they flipped the hourly part up.It seems to be the clip was only good for the first or second use.It was noticeable straight away and the contents spill, it was not a slow leak.The affected bags were not available.Stated that this was a safety issue.Enough events had occurred that their staff were all saying there was an issue with the product.They have had (perhaps 5) staff tell the representative they have had exposure to body fluids from the product faults.Stated that they were hoping it was a user error and not something that was unidentifiable to help all staff avoid this issue in the future.They were attending the ward for product training next week in the event it was user error and they have asked them to keep the bag if it happens again so they can collect it and record batch numbers.It was unknown what medical intervention was provided.

Event Description

It was reported that the customer had a bard urine meter with bag and safety-flow outlet device which have multiple issues with these leaking.As per follow-up information received from ibc on (b)(6)2023, stated that the problems had been occurring since they took delivery of these products.They don¿t have a batch number.The leak occurred on the second or third empty when they flipped the hourly part up.It seems to be the clip was only good for the first or second use.It was noticeable straight away and the contents spill, it was not a slow leak.The affected bags were not available.Stated that this was a safety issue.Enough events had occurred that their staff were all saying there was an issue with the product.They have had (perhaps 5) staff tell the representative they have had exposure to body fluids from the product faults.Stated that they were hoping it was a user error and not something that was unidentifiable to help all staff avoid this issue in the future.They were attending the ward for product training next week in the event it was user error and they have asked them to keep the bag if it happens again so they can collect it and record batch numbers.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect outlet tube assembly to the bag¿s port." 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 dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.1.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.2.Unsnap hook.3.Position hanger on bedside rail near the foot of the bed using string or hook.4.Use sheeting clip to secure drainage tube to sheet.Important: hang drainage tube in a straight fashion from bedside to drainage bag.5.To empty bag:.Open - with thumb on top of device and finger under green lever, lift and rotate counterclockwise.Close - with thumb on green lever and finger on lever support bar,rotate lever clockwise.Note: if specimen is required, see directions for using urine sample port.6.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.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.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® URINE METER WITH BAG
• Type of Device: URINE METER WITH 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: 17037296
• MDR Text Key: 316289813
• Report Number: 1018233-2023-03960
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741033186
• UDI-Public: (01)00801741033186
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 153216
• Device Catalogue Number: 153216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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