MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INTRA-ABDOMINAL 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	07/06/2021
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 four intra-abdominal pressure measurement kit devices all leaked at the valve to the point that fluid would not flow properly.Four devices were attempted to be used on the same patient.They were able to get one to work enough to use it, but it also leaked.Per customer via phone on (b)(6) 2021, there were four intra-abdominal pressure measurement kits used on the same patient, and each one was noted to be leaking after an hour or so.A new kit was then opened and used.It was stated that there was no patient harm.
Event or Problem Description
It was reported that four intra abdominal pressure measurement kit devices which all leaked at the valve to the point that fluid would not flow properly.Four devices were attempted to be used on the same patient.They were able to get one to work enough to use it but it also leaked.Per customer via phone on (b)(6) 2021,there were 4 intra abdominal pressure measurement kits were used on the same patient and each one was noted to be leaking after an hour or so.A new kit was then opened and used and there was no patient harm.Per follow up via phone on (b)(6) 2021, customer stated the fluid mentioned would not flow properly was urine.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used iap kit.Visual inspection of the sample noted that the sample port connector piece was completely disconnected on the return sample.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not completed as they are addressed by existing capa.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.

• Brand Name: BARD® INTRA-ABDOMINAL PRESSURE MONITORING DEVICE
• Common Device Name: INTRA-ABDOMINAL 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12631926
• Report Number: 1018233-2021-06412
• Device Sequence Number: 19690914
• Product Code: PHU
• UDI-Device Identifier: 00801741121098
• UDI-Public: (01)00801741121098
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Expiration Date: 02/28/2022
• Device Model Number: IAP001
• Device Catalogue Number: IAP001
• Device Lot Number: NGDP3845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2019
• 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