MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; DRAIN BAG

Model Number	900016A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
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.
Event or Problem Description
It was reported that there were foreign substances such as human hair was found inside the drain bag upon opening the package.
Event or Problem Description
It was reported that there were foreign substances such as human hair was found inside the drain bag upon opening the package.
Additional Manufacturer Narrative
The reported event was confirmed ¿ manufacturing related.The reported failure was able to be reproduced.The product was used for urological care.Sample was evaluated and observed the was hair trapped at sealing area.View under microscopic examination vs actual human hair had confirmed the human hair trapped at sealing area.Hair may have come into contact with the sample during packaging operation.The potential root cause for this failure mode could be due to improper handling/unclean machine / working area.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indication for use 1.Take off the drainage bag cap with careful for sterile of inlet tube.Then connect with foley catheter 2.Fix the drainage bag securely on the patient bed etc.Using the hanger/belt to prevent the bag from sudden movement and to avoid direct contact with floor.Keep the drainage bag below the level of patient bladder to keep urine flowing freely.3.Drain tubing must be secured using sheeting clip, keeping the tubing line straight with no kink to avoid obstructed urine flow into drainage bag.Kinked of or flexed drain tubing will restrict urine flow.4.Lift cock up and pass urine precautions 1.Do not let the distal end of the outlet tube touch the urine collection container when emptying the bag in order not to permit bacterial contamination into drainage bag.2.Care should be taken where the bag should be positioned to avoid damage by bump or projection.3.Do not pull outlet tube on urinating.It might break the product." 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 actual/suspected device was inspected.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Common Device Name: DRAIN BAG
• 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: 15028804
• Report Number: 1018233-2022-05501
• Device Sequence Number: 6357627
• Product Code: MJC
• UDI-Device Identifier: 00801741019371
• UDI-Public: (01)00801741019371
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040658
• 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): 09/21/2022

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: 900016A
• Device Catalogue Number: 900016A
• Device Lot Number: MYFZ2210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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