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

Model Number	166816
Medical Device Problem Codes	Material Invagination (1336); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/06/2020
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 device was not returned.
Event or Problem Description
It was reported that the foley catheter had an unknown issue.Additional information has been requested.Per follow-up information received from (b)(6) team on 20apr2022, the foley catheter had a material deformation problem and mechanical jam problem.It was also stated that the patient experienced hemorrhage/bleeding.It was unknown if the device contributed to the hemorrhage/bleeding at this time and medical intervention was unknown.No other information was available.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect balloon design (balloon wall thickness excessive)".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is 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 fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: f, h h11: section a through f - 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley catheter had an unknown issue.Per follow-up information received on (b)(6) 2022, the foley catheter had a material deformation problem and mechanical jam problem.It was also stated that the patient experienced hemorrhage/bleeding.Per follow-up information received on (b)(6) 2022, foley catheter was removed and got stuck on the way out causing urethral trauma and bleeding with removal and post removal.Upon inspection of the catheter post removal, there were wrinkles and rolls in the area where the balloon was inflated, frank blood noted on the area and in the tip of the catheter.The patient also experienced urethra tissue breakdown while the catheter was inserted, despite the securement of the catheter to the patient's thigh, possibly due to the rigid nature of the product.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "inappropriate package design".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.Corrections: b,g 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.
Event or Problem Description
It was reported that the foley catheter had an unknown issue.Additional information has been requested.Per follow-up information received on 20apr2022, the foley catheter had a material deformation problem and mechanical jam problem.It was also stated that the patient experienced hemorrhage/bleeding.No medical intervention was reported.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• 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: 14402916
• Report Number: 1018233-2022-03748
• Device Sequence Number: 17527300
• Product Code: GBM
• UDI-Device Identifier: 00801741029806
• UDI-Public: (01)00801741029806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K760093
• 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,Followup
• Report Date (Section B): 09/14/2022

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: 166816
• Device Catalogue Number: 166816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 09/14/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/11/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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