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

Device Problem Burst Container or Vessel (1074)

Patient Problem Discomfort (2330)

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that the urinary catheter balloon leaked/collapsed while attempting to insert the foley urinary catheter.While placing a new foley catheter (18 fr non-latex 30 ml balloon), the nurse used 10 ml of sterile saline to start inflating the balloon.There was a mild report of discomfort and 5 ml more sterile saline was instilled when pulling back, but no saline returned.Foley removed and noted the balloon was not inflated and that there were s-shaped flaps where the balloon was supposed to be.No medical intervention was reported.

Event Description

It was reported that the urinary catheter balloon leaked/collapsed while attempting to insert the foley urinary catheter.While placing a new foley catheter (18 fr non-latex 30 ml balloon), the nurse used 10 ml of sterile saline to start inflating the balloon.There was a mild report of discomfort and 5 ml more sterile saline was instilled when pulling back, but no saline returned.Foley removed and noted the balloon was not inflated and that there were s-shaped flaps where the balloon was supposed to be.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "high modulus silicone".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 device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.H3 other text : the device was not returned.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: ALL SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16938447
• MDR Text Key: 315307009
• Report Number: 1018233-2023-03452
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other