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

Model Number	FOL0101
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the statlock did not hold the hose, and it randomly disconnected.Per additional information received via phone from the customer on (b)(6) 2021, it was stated that the customer was trying to put a clip around both the catheter and the access port which made it difficult to coordinate, and then it would disconnect and not hold the catheter in place.It was also stated that the customer was only able to get the catheter into the clip.Discussed with the customer that the diagram indicated the correct place to lip the statlock (under the y union and only on the large catheter).The customer stated that they will call back if the problem continues.

• Brand Name: SL FOLEY SWIVEL SILICONE 25BX
• Common Device Name: FOLEY STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12401715
• Report Number: 1018233-2021-05319
• Device Sequence Number: 4030308
• Product Code: EYJ
• UDI-Device Identifier: 00801741076091
• UDI-Public: (01)00801741076091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Model Number: FOL0101
• Device Catalogue Number: FOL0101
• Device Lot Number: JUEY2779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other