MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER

Model Number	942616
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Patient Problem/Medical Problem (2688)
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 foley catheter was met with resistance upon removal.The balloon was reportedly deflated and the patient experienced pain and bleeding at the meatus.When the catheter was removed, the balloon was noted to have folded in on itself, ¿creating a rivet like appearance.¿ the balloon was reportedly inflated and deflated to observe the same folding in action.No medical intervention was required.
Additional Manufacturer Narrative
The reported event is unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.Visual inspection of the sample noted no obvious visible defects such as ridges.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issues such as ridges or mushrooming, returning 10ml of solution.Active length of the catheter balloon was measured (0.8385") and found to be within specification (0.6"-0.9").The catheter was confirmed to be 16 fr.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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than i required to make the syringe "stick" in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this falls, contact adequately trained professional for assistance, as directed by hospital protocol.".
Event or Problem Description
It was reported that the foley catheter was met with resistance upon removal.The balloon was reportedly deflated and the patient experienced pain and bleeding at the meatus.When the catheter was removed, the balloon was noted to have folded in on itself, ¿creating a rivet like appearance.¿ the balloon was reportedly inflated and deflated to observe the same folding in action.No medical intervention was required.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8420908
• Report Number: 1018233-2019-01290
• Device Sequence Number: 239968
• Product Code: MJC
• UDI-Device Identifier: 00801741024832
• UDI-Public: (01)00801741024832
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• 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): 06/04/2019

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: 10/09/2023
• Device Model Number: 942616
• Device Catalogue Number: 119316M
• Device Lot Number: NGCW1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1