MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE

Catalog Number FOL0102

Device Problem Disconnection (1171)

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

Event Date 09/27/2021

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 foley catheter was almost out of the urethra and when inserted, there was blood in the drainage bag.It was noted that the patient had been using the product for less than 90 days.No medical intervention was reported.Per additional information received from customer via phone on 27sep2021, it was stated that while the foley catheter was inserted, the customer felt it popped and then there was a lot of bleeding.It was stated that the customer went to the doctor and they placed a new foley catheter and did a thorough examination.There was no medication required.It was also stated that a statlock was being used and the swivel clip came off of the mounting pad.The customer stated it only had adhesive on half of the disc and this occurred only about 1 hour into use.As per the follow up done by the liberator to the customer on (b)(6) 2021, the patient felt that the foley balloon popped which caused major bleeding and lots of pain and the patient had to go to the hospital for a few days.Then the patient stated that the next catheter was used and had a pinhole which caused leaking.

Event Description

It was reported that the foley catheter was almost out of the urethra and when inserted, there was blood in the drainage bag.It was noted that the patient had been using the product for less than 90 days.No medical intervention was reported.Per additional information received from customer via phone on (b)(6) 2021, it was stated that while the foley catheter was inserted, the customer felt it popped and then there was a lot of bleeding.It was stated that the customer went to the doctor and they placed a new foley catheter and did a thorough examination.There was no medication required.It was also stated that a statlock was being used and the swivel clip came off of the mounting pad.The customer stated it only had adhesive on half of the disc and this occurred only about 1 hour into use.As per the follow up done by the liberator to the customer on (b)(6) 2021, the patient felt that the foley balloon popped which caused major bleeding and lots of pain and the patient had to go to the hospital for a few days.Then the patient stated that the next catheter was used and had a pinhole which caused leaking.Per additional information on 13oct2021, it was reported that the nurse put the statlock and 2 hours later the clip popped off.

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.

Event Description

It was reported that the foley catheter was almost out of the urethra and when inserted, there was blood in the drainage bag.It was noted that the patient had been using the product for less than 90 days.No medical intervention was reported.Per additional information received from customer via phone on 27sep2021, it was stated that while the foley catheter was inserted, the customer felt it popped and then there was a lot of bleeding.It was stated that the customer went to the doctor and they placed a new foley catheter and did a thorough examination.There was no medication required.It was also stated that a statlock was being used and the swivel clip came off of the mounting pad.The customer stated it only had adhesive on half of the disc and this occurred only about 1 hour into use.As per the follow up done by the liberator to the customer on 28sep2021, the patient felt that the foley balloon popped which caused major bleeding and lots of pain and the patient had to go to the hospital for a few days.Then the patient stated that the next catheter was used and had a pinhole which caused leaking.Per additional information on 13oct2021, it was reported that the nurse put the statlock and 2 hours later the clip popped off.

Manufacturer Narrative

The reported event is confirmed and cause unknown.Visual evaluation noted one used statlock was received.Visual inspection noted that the swivel base with clamp was disconnected from the pad.This does not meet specifications states "clamp should be bonded to the stabilization pad." although an exact root cause could not be determined, a potential root cause is operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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 evaluated.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12640808
• MDR Text Key: 276865255
• Report Number: 1018233-2021-06441
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

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
• Device Expiration Date: 05/28/2024
• Device Catalogue Number: FOL0102
• Device Lot Number: JUFS1991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 02/11/2022
• Supplement Dates FDA Received: 11/03/2021; 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2021
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White