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

Model Number 0165SI16

Device Problem Nonstandard Device (1420)

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

Event Date 10/29/2021

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 found to be broken on the sixth day after placement.It was also stated that the damage might be caused by the protrusion of the statlock.Per follow-up information received from ibc on 09nov2021, stated that the normal protruding part inside the statlock retainer hit or rubbed against the catheter, causing the catheter to break.

Event Description

It was reported that the foley catheter was found to be broken on the sixth day after placement.It was also stated that the damage might be caused by the protrusion of the statlock.Per follow-up information received from ibc on 09nov2021, stated that the normal protruding part inside the statlock retainer hit or rubbed against the catheter, causing the catheter to break.

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 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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "retainer teeth cut into catheter".It was unknown whether the device had met specifications.The product was used for treatment purpose.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number of this device were unknown.Therefore, bd is unable to determine the associated labeling to review.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 device was not returned.

Event Description

It was reported that the foley catheter was found to be broken on the sixth day after placement.It was also stated that the damage might be caused by the protrusion of the statlock.Per follow-up information received from ibc on 09nov2021, stated that the normal protruding part inside the statlock retainer hit or rubbed against the catheter, causing the catheter to break.Per sample evaluation email received on 28feb2022, the catheter damage was confirmed.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN 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: 12856089
• MDR Text Key: 283790806
• Report Number: 1018233-2021-07449
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI16
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• 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 Sex: Male