MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX 30CC LUBRICATH LATEX 3-WAY FOLEY CATHETER, TWO STAGGERED EYES

Model Number	0167L22
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
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.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.
Event or Problem Description
It was reported that the balloon inflation port was punctured.The balloon, subsequently did not remain inflated post-insertion.The foley allegedly slipped out of patient requiring re-catheterization a few hours post-op.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection found a hole/tear in the inflation arm.The hole/tear allowed the sample to leak.The balloon was intact.Unable to determine if the hole/tear occurred prior to or after use.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the balloon inflation port was punctured.The balloon, subsequently did not remain inflated post-insertion.The foley allegedly slipped out of patient requiring re-catheterization a few hours post-op.

• Brand Name: BARDEX 30CC LUBRICATH LATEX 3-WAY FOLEY CATHETER, TWO STAGGERED EYES
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• MDR Report Key: 6536645
• Report Number: 1018233-2017-02204
• Device Sequence Number: 750133
• Product Code: KOD
• UDI-Device Identifier: 00801741018978
• UDI-Public: (01)00801741018978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 06/30/2021
• Device Model Number: 0167L22
• Device Catalogue Number: 0167L22
• Device Lot Number: HH6032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1