MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; STATLOCK DEVICE

Device Problem Nonstandard Device (1420)

Patient Problem Urinary Retention (2119)

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported that with 3 (three) separate foley statlock stabilization devices, the customer believed the stabilization device was crimping the catheter tubing and creating a problem for the urine flow.It was noted that there was no sediment in the tube and no issue with the catheter.There was a snap to keep the device in place, thus the customer could not put the device on incorrectly.More often than not, the butterfly stabilization device was in place and snapped, but no urine would go through the foley catheter tubing into the foley bag.It was noted that this issue was not due to lack of gravity.As soon as the foley catheter tubing was unsnapped, the bag would be filled.The customer believed the foley was cutting off the urine flow from the catheter.There would be 8-9 hours with no urine flow, but once the stabilization device was replaced with tape or just free hanging, the urine flow would be instant.Tubes clear, properly installed.The customer feared people could die from ruptured bladders, urinary tract infections (utis), or kidney infections.The customer also stated this was a continuous issue, not just single time.At one point in the hospital, there was no urine movement over 9-10 hours.Upon seeing this, the device was unsnapped, and within about 2 minutes the larger bag almost filled to capacity.The stabilization device was snapped back to change the bag.As soon as the bag was replaced and the device unsnapped, urine flow resumed.The patient was given plenty of fluids, so the customer did not believe this was a urine issue.The customer believed the issue was related to the statlock device.The patient was sedentary while foley catheter and the stabilization device was in place.The patient did not have the ability to stand or walk, so the patient¿s family assisted with moving the patient side-to-side and raising/lowering the upper and lower part of the bed.The patient experienced a urinary tract infection (uti), but it is unknown whether the uti was related to the device.Medical intervention was unknown.Per follow up via email on (b)(6) 2023, the patient¿s wife confirmed the statlock stabilization device could not be closed/snapped into place if the catheter tube was not in proper position.She reported that the patient passed away on (b)(6) 2023.No additional information was provided.Per clinical follow up via phone on (b)(6) 2023, the patient¿s wife reported the patient had brain cancer.He was receiving radiation therapy and chemotherapy.He was additionally preparing to begin immunotherapy.The patient was initially admitted to the hospital due to loss of mobility.While the patient was in the hospital, he experienced difficulty urinating.The patient was diagnosed with a uti, and a foley catheter was inserted.While the patient was in the hospital, the foley catheter was secured in place with tape.The patient was discharged from the hospital on (b)(6) 2023 with the foley catheter in place.The home health nurse supplied the statlock stabilization devices.The patient¿s wife confirmed the statlock was applied correctly, and the catheter tubing was in correct position when she noted there was no urine flow.When she removed the foley catheter tubing from the statlock device, urine began to flow.The statlock was replaced, but the same issue occurred.On (b)(6) 2023, the patient experienced rectal bleeding, and he was admitted to the hospital due to diverticulitis.The patient¿s wife stated while the patient was in the hospital the second time, they continued to have issues with the foley catheter not draining because of the statlock device.The foley catheter tubing had to be removed from the statlock in order for urine to drain.The 61-year-old male patient passed away in the hospital on (b)(6) 2023 due to complications from brain cancer.The patient¿s wife confirmed the patient¿s death was unrelated to the statlock device.

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.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be ¿excessive patient movement".A 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.

Event Description

It was reported that with 3 (three) separate foley statlock stabilization devices, the customer believed the stabilization device was crimping the catheter tubing and creating a problem for the urine flow.It was noted that there was no sediment in the tube and no issue with the catheter.There was a snap to keep the device in place, thus the customer could not put the device on incorrectly.More often than not, the butterfly stabilization device was in place and snapped, but no urine would go through the foley catheter tubing into the foley bag.It was noted that this issue was not due to lack of gravity.As soon as the foley catheter tubing was unsnapped, the bag would be filled.The customer believed the foley was cutting off the urine flow from the catheter.There would be 8-9 hours with no urine flow, but once the stabilization device was replaced with tape or just free hanging, the urine flow would be instant.Tubes clear, properly installed.The customer feared people could die from ruptured bladders, urinary tract infections (utis), or kidney infections.The customer also stated this was a continuous issue, not just single time.At one point in the hospital, there was no urine movement over 9-10 hours.Upon seeing this, the device was unsnapped, and within about 2 minutes the larger bag almost filled to capacity.The stabilization device was snapped back to change the bag.As soon as the bag was replaced and the device unsnapped, urine flow resumed.The patient was given plenty of fluids, so the customer did not believe this was a urine issue.The customer believed the issue was related to the statlock device.The patient was sedentary while foley catheter and the stabilization device was in place.The patient did not have the ability to stand or walk, so the patient¿s family assisted with moving the patient side-to-side, and raising/lowering the upper and lower part of the bed.The patient experienced a urinary tract infection (uti), but it is unknown whether the uti was related to the device.Medical intervention was unknown.As per follow up via email on (b)(6) 2023, the patient¿s wife confirmed the statlock stabilization device could not be closed/snapped into place if the catheter tube was not in proper position.She reported that the patient passed away on 24-may-2023.No additional information was provided.As per clinical follow up via phone on (b)(6) 2023, the patient¿s wife reported the patient had brain cancer.He was receiving radiation therapy and chemotherapy.He was additionally preparing to begin immunotherapy.The patient was initially admitted to the hospital due to loss of mobility.While the patient was in the hospital, he experienced difficulty urinating.The patient was diagnosed with a uti, and a foley catheter was inserted.While the patient was in the hospital, the foley catheter was secured in place with tape.The patient was discharged from the hospital on (b)(6) 2023 with the foley catheter in place.The home health nurse supplied the statlock stabilization devices.The patient¿s wife confirmed the statlock was applied correctly, and the catheter tubing was in correct position when she noted there was no urine flow.When she removed the foley catheter tubing from the statlock device, urine began to flow.The statlock was replaced, but the same issue occurred.On (b)(6) 2023, the patient experienced rectal bleeding, and he was admitted to the hospital due to diverticulitis.The patient¿s wife stated while the patient was in the hospital the second time, they continued to have issues with the foley catheter not draining because of the statlock device.The foley catheter tubing had to be removed from the statlock in order for urine to drain.The 61-year-old male patient passed away in the hospital on (b)(6) 2023 due to complications from brain cancer.The patient¿s wife confirmed the patient¿s death was unrelated to the statlock device.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK DEVICE
• 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: 17603974
• MDR Text Key: 321750012
• Report Number: 1018233-2023-06238
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/25/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male