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

Model Number	IAP001
Medical Device Problem Codes	Disconnection (1171); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 water did not flow appropriately from the intra abdominal pressure monitoring device kit due to connection failure.
Event or Problem Description
It was reported that the water did not flow appropriately from the intra abdominal pressure monitoring device kit due to connection failure.
Additional Manufacturer Narrative
The reported event was confirmed as a manufacturing related.One sample was confirmed to exhibit the reported failure.The device did not meet the 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 no obvious visible defects.The methylene blue solution (3 drops 1% aqueous methylene blue per 100ml distilled water) was injected into the system and leaked out near the sample port threaded cap.The threaded cap was examined to be off center.A potential root cause for this failure mode could be due to the materials were out of specifications.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The labeling review was not performed due to the labelling could not have prevented the reported failure.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.

• 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: 11905862
• Report Number: 1018233-2021-03118
• Device Sequence Number: 3596666
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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 Model Number: IAP001
• Device Catalogue Number: IAP001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 05/30/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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