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

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	02/08/2021
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 leaked from the base of the connection to the sample port.
Additional Manufacturer Narrative
The reported event was confirmed.The root cause was found to be manufacturing related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.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.Methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) was injected into the sample port and leaked out of the area where the tubing connects to the sample port.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.A lack adequate inspection method to test for leaks is also identified as a contributing cause for not identifying non-conforming product in the inspections].The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the water leaked from the base of the connection to the sample port.

• Brand Name: BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE
• Common Device Name: INTRA-ABDOMINAL PRESSURE MONITORING DEVICE (IAP)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11553277
• Report Number: 1018233-2021-01508
• Device Sequence Number: 14409939
• 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): 08/08/2021

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: 02/28/2023
• Device Model Number: IAP001
• Device Catalogue Number: IAP001
• Device Lot Number: NGEP4032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other