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	05/24/2021
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 water leak occurred from the sample port of intra-abdominal pressure monitoring device and user did not want to use it further because the lot number of the device was similar to the lot number of the recalled intra-abdominal pressure monitoring device lots in market.
Additional Manufacturer Narrative
The reported event was confirmed by capa association.Per capa 1132938, the root causes for this failure are: "as a first potential root cause we found that the solvent is not evenly distributed in the tube with the appropriate amount of adhesive, the training of the personal is crucial on this operation and the preparation of the dispenser of cyclo.The amount applied may vary on the dipping of the tube depending on the height (amount) of the solvent given at the beginning.The uniform distribution of the adhesive is also affected by the twisting operation performed after the dipping.Visual inspection noted one used, one opened, and one unopened intra-abdominal pressure monitoring devices received.Methylene blue was injected into the sample port connection, and two of the devices leaked from the sample port connection to the tubing.This does not meet specification which states " assembly must not leak after ultrasonic welding." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the complaint was addressed by existing capa.Correction: 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.
Event or Problem Description
It was reported that water leak occurred from the sample port of intra-abdominal pressure monitoring device and user did not want to use it further because the lot number of the device was similar to the lot number of the recalled intra-abdominal pressure monitoring device lots in market.

• 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: 12030023
• Report Number: 1018233-2021-03638
• Device Sequence Number: 4269385
• Product Code: PHU
• UDI-Device Identifier: 00801741121098
• UDI-Public: (01)00801741121098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 05/31/2023
• Device Model Number: IAP001
• Device Catalogue Number: IAP001
• Device Lot Number: NGES1280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 06/19/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2020
• 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