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

Model Number 119216M

Device Problems Burst Container or Vessel (1074); Component Missing (2306)

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.The device was not returned.

Event Description

It was reported that the foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities." 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.H3 other text : the device was not returned.

Event Description

It was reported that the foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted one temperature sensing catheter attached to a cut portion of the inlet tubing was received without the original packaging.No obvious defects were noted.The catheter balloon was inflated with 10 ml 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 issue or cuffing, returning 10ml of solution.Active length of the catheter balloon was measured (0.6560") and found to be within specification (0.60" - 0.90").The catheter measured to be 16 fr.A full device history record was not reviewed due to the reported event being unconfirmed.The instructions for use were found adequate and state the following: ¿recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities." correction: d4, d10, h3, h6, h10.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 foley balloon burst mid case and stopped draining urine.No pieces were reported to be missing.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9190126
• MDR Text Key: 167999808
• Report Number: 1018233-2019-06451
• 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: 11/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2024
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDR4136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 09/22/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 11/15/2019
• Supplement Dates FDA Received: 10/17/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1