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

Catalog Number UNKNOWN

Device Problem Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

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 customer had issue with indwelling catheter.It was stated that the catheter was placed on 9months female in operating room on (b)(6) and removed on (b)(6) by a bedside nurse.Documentation stated the catheter was 6fr filled with 3cc and took 2 attempts.Upon removing nurse deflated the bulb passively and got 3cc back, when attempted to pull the catheter nurse met resistance.When the catheter was removed it was noted that the bulb had folded back and had formed a ridge.Per additional information received via email on 24dec2022, no medical intervention was required.Per follow-up via email on 17jan2023, it was reported that the customer had another issue with an indwelling catheter on 16jan.The nurse placed an in-and-out catheter (the one with a bag attached) to obtain a specimen and relieve bladder pressure.Approximately 700 cc of urine were returned.Upon trying to remove the catheter, resistance was felt, so the bedside nurse stopped and called them.They tried pushing the catheter back in (without resistance) and applied more lubrication but were not able to remove the catheter, so the physician team was notified, urology was consulted, and they came to the bedside and removed the catheter.It was also stated that the intermittent catheter pre-made kit had been opened.The iodine swab pack in the kit contained only iodine and did not contain any swabs.Per additional information received via email on 14feb2023, it was reported that the customer had another issue with the foley catheter.Stated that the bedside nurse attempted to place a catheter, when going to inflate the balloon met a lot of resistance and was unable to inflate despite being in bladder, as urine was filling bag.Staff removed this catheter and attempted again, unable to inflate that was as well.Then consulted urology and they came to the bedside and placed a foley.Staff have attached a picture of the first catheter after removal, they tried to re-inflate it and only one side inflated.

Event Description

It was reported that the customer had issue with indwelling catheter.It was stated that the catheter was placed on 9months female in operating room on (b)(6) and removed on (b)(6) by a bedside nurse.Documentation stated the catheter was 6fr filled with 3cc and took 2 attempts.Upon removing nurse deflated the bulb passively and got 3cc back, when attempted to pull the catheter nurse met resistance.When the catheter was removed it was noted that the bulb had folded back and had formed a ridge.Per additional information received via email on 24dec2022, no medical intervention was required.Per follow-up via email on 17jan2023, it was reported that the customer had another issue with an indwelling catheter on (b)(6).The nurse placed an in-and-out catheter (the one with a bag attached) to obtain a specimen and relieve bladder pressure.Approximately 700 cc of urine were returned.Upon trying to remove the catheter, resistance was felt, so the bedside nurse stopped and called them.They tried pushing the catheter back in (without resistance) and applied more lubrication but were not able to remove the catheter, so the physician team was notified, urology was consulted, and they came to the bedside and removed the catheter.It was also stated that the intermittent catheter pre-made kit had been opened.The iodine swab pack in the kit contained only iodine and did not contain any swabs.Per additional information received via email on 14feb2023, it was reported that the customer had another issue with the foley catheter.Stated that the bedside nurse attempted to place a catheter, when going to inflate the balloon met a lot of resistance and was unable to inflate despite being in bladder, as urine was filling bag.Staff removed this catheter and attempted again, unable to inflate that was as well.Then consulted urology and they came to the bedside and placed a foley.Staff have attached a picture of the first catheter after removal, they tried to re-inflate it and only one side inflated.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted received one photo sample which focuses in on inflated asymmetrical balloon with solution.Although an exact root cause could not determined a potential root cause could be shaft strength (materials of shaft is too soft and torsion occurs - not enough support).Dhr review is not required as no lot number was reported.Labelling review is not required as no product catalog number was reported.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 actual/suspected device was inspected.

• Brand Name: SILICONE FOLEY CATHETER
• Type of Device: UNKNOWN SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16501674
• MDR Text Key: 310871768
• Report Number: 1018233-2023-01501
• 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: 04/13/2023

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
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 04/18/2023
• 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