MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER; TEMPSENSING CATHETER

Model Number 119216M

Device Problems Deflation Problem (1149); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the patient returned from or open heart surgery and the foley catheter was noted to be in bed a while later.The nurse checked the foley and noted that there was a pin size hole in the silicone foley balloon.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed.The device was used for treatment.The device was out of specification.The device was influenced by the failure.Visual evaluation of the sample noted one used silicone foley without original packaging.Visual inspection of the sample noted no visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and solution streamed out from a 0.012" pinhole in the balloon surface.No balloon pieces were missing.Pinholes are not permitted per the standard.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be damaged tooling (core pins).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: ¿warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.Refer to the instructions for use.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.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.".

Event Description

It was reported that the patient returned from or open heart surgery and the foley catheter was noted to be in bed a while later.The nurse checked the foley and noted that there was a pin size hole in the silicone foley balloon.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed.The device was used for treatment.The device was out of specification.The device was influenced by the failure.Visual evaluation of the sample noted one used silicone foley without original packaging.Visual inspection of the sample noted no visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and solution streamed out from a 0.012" pinhole in the balloon surface.No balloon pieces were missing.Pinholes are not permitted per the standard.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be damaged tooling (core pins).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: ¿warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.Refer to the instructions for use.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.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." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the patient returned from or open heart surgery and the foley catheter was noted to be in bed a while later.The nurse checked the foley and noted that there was a pin size hole in the silicone foley balloon.No medical intervention was reported.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPSENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9317963
• MDR Text Key: 177830557
• Report Number: 1018233-2019-07294
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDP2428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 12/27/2019
• Supplement Dates FDA Received: 12/13/2019; 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1