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

Device Problem Dent in Material (2526)

Patient Problems Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

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 urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.

Event Description

It was reported that the urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.As per follow up response received via email on 05oct2022, stated that the patient's foley order was discontinued.The foley catheter's balloon was documented as being filled with 5 ml.The nurse deflated the balloon, only refracting approximately four mls.Registered nurse tried two more times to deflate the balloon but only extracted air.Registered nurse the began to remove the foley catheter from patient's urethra and no resistance was met until the tip of the catheter met the tip of the patient's penis.The resistance was not resolved with gentle tugging.It appeared that the foley was stuck in the penis.The registered nurse called one the procedure nurses who then brought in the nurse practitioner.Nurse practitioner applied more force after examining the situation and penis and the foley came out.Stated that upon examination, the foley catheter's deflated balloon had made a wrinkle around the foley which had been the reason the foley met resistance at the end of the penis.The nurse practitioner inflated the balloon of the foley, then out of the patient and all three healthcare professionals saw that the balloon did not inflate equally around the tube , leading all three to wonder if the defect in the product caused more trauma than necessary to the patient's urethra.Urethra was more red than normal after removal.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event is inconclusive due to sample received condition, which unable to perform the test.It is unknown whether the device had met relevant specifications.The product was used for patient treatment or diagnosis.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be balloon molding.Visual evaluation of the returned sample noted one opened (without original packaging),1 foley catheter.Visual inspection noted that the inflation arm and funnel were cut off.Due to the inflation arm and funnel being cut off, it is not possible to inflate the sample as the size of the syringe head itself is bigger than the shaft of the catheter.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is 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 actual/suspected device was inspected.

Event Description

It was reported that the urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.As per follow up response received via email on 05oct2022, stated that the patient's foley order was discontinued.The foley catheter's balloon was documented as being filled with 5 ml.The nurse deflated the balloon, only refracting approximately four mls.Registered nurse tried two more times to deflate the balloon but only extracted air.Registered nurse the began to remove the foley catheter from patient's urethra and no resistance was met until the tip of the catheter met the tip of the patient's penis.The resistance was not resolved with gentle tugging.It appeared that the foley was stuck in the penis.The registered nurse called one the procedure nurses who then brought in the nurse practitioner.Nurse practitioner applied more force after examining the situation and penis and the foley came out.Stated that upon examination, the foley catheter's deflated balloon had made a wrinkle around the foley which had been the reason the foley met resistance at the end of the penis.The nurse practitioner inflated the balloon of the foley, then out of the patient and all three healthcare professionals saw that the balloon did not inflate equally around the tube , leading all three to wonder if the defect in the product caused more trauma than necessary to the patient's urethra.Urethra was more red than normal after removal.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: 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: 15499978
• MDR Text Key: 306286662
• Report Number: 1018233-2022-07350
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 02/22/2023
• Supplement Dates FDA Received: 01/20/2023; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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