MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INTRA-ABDOMINAL PRESSURE MONITORING DEVICE; INTRAABDOMINAL PRESSURE MONITORING DEVICE

Model Number	IAP001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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 information provided by bd 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 bd.
Event or Problem Description
It was reported that when instilling saline into the bladder to measure the pressure, saline leaked from the tubing that was fused to the connector which attached to the urinary catheter drainage system.The system was changed out, and the new system was also leaking from the same place.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "insufficient adhesive -no adhesive -incorrect or expired adhesive incorrect bonding method id of sample port greater than specified.Tube od smaller than specified.".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 instructions for use were found adequate and state the following: "indications for use: the bard® intra-abdominal pressure (iap) monitoring device is intended for the monitoring of intra-abdominal pressure via a foley urinary catheter.The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (iah) and the associated clinical syndrome of abdominal compartment syndrome (acs).Device description: the bard® intra-abdominal pressure monitoring device is composed of a tubing set used for infusing fluid into the urinary bladder through the foley catheter sampling port.It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.Important: the bard® intra-abdominal pressure monitoring device does not include a saline bag, pressure transducer or monitoring system.It adapts to the saline bag, pressure transducer and monitoring system used in your icu.The bard® intra-abdominal pressure monitoring device must be replaced at the time the urinary catheter and/or urinary drainage tubing is replaced.The bard® intra-abdominal pressure monitoring device is for use with bard® foley trays with ez-lok¿ sampling port.Contraindications ¿ not for use on pediatric patients ¿ not for use on patients with compromised bladder function warnings ¿ use only saline for pressure measurement.¿ ensure tubing fluid path is primed so there are no air bubbles.¿ ensure the iap sampling port is seated tightly to the catheter drainage tubing sampling port prior to use.Precautions ¿ single use only ¿ federal (u.S.A.) law restricts this device to sale by or on the order of a physician.¿ not made with natural rubber latex ¿ sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.¿ this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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 or Problem Description
It was reported that when instilling saline into the bladder to measure the pressure, saline leaked from the tubing that was fused to the connector which attached to the urinary catheter drainage system.The system was changed out, and the new system was also leaking from the same place.

• Brand Name: BARD® INTRA-ABDOMINAL PRESSURE MONITORING DEVICE
• Common Device Name: INTRAABDOMINAL PRESSURE MONITORING DEVICE
• 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: 14670914
• Report Number: 1018233-2022-04544
• Device Sequence Number: 6774397
• Product Code: PHU
• UDI-Device Identifier: 00801741121098
• UDI-Public: (01)00801741121098
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070201
• 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
• Report Date (Section B): 11/09/2022

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: IAP001
• Device Catalogue Number: IAP001
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 06/11/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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