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

Catalog Number Z097FO

Device Problem Fitting Problem (2183)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that customer having trouble with the statlock (fol0100, fol0102) on patient catheter.Patient recently moved up from up to 18fr lubrisil foley catheter and noticed the other day it was pinching the foley to the point that the urine was coming out from around the foley (at urethra site) (z097fo).Representative advised our statlocks are made to fit 6-26fr foley catheters.If the foley catheter did not fit into the statlock@ foley device clamp, then check to be certain the directional arrow on the retainer clamp was facing the tip of the catheter and that the foley arms were placed in the correct channels.If the catheter still did not fit, place only the balloon arm into the narrow channel and leave the other arm outside of the clamp.Customer stated this was the first time this had happened in 8 years.

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.H3 other text : the device was not returned.

Event Description

It was reported that customer having trouble with the statlock (fol0100, fol0102) on patient catheter.Patient recently moved up from up to 18fr lubrisil foley catheter and noticed the other day it was pinching the foley to the point that the urine was coming out from around the foley (at urethra site) (z097fo).Representative advised our statlocks are made to fit 6-26fr foley catheters.If the foley catheter did not fit into the statlock@ foley device clamp, then check to be certain the directional arrow on the retainer clamp was facing the tip of the catheter and that the foley arms were placed in the correct channels.If the catheter still did not fit, place only the balloon arm into the narrow channel and leave the other arm outside of the clamp.Customer stated this was the first time this had happened in 8 years.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "inappropriate snap fit".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was 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.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK SL FOLEY
• 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: 17266223
• MDR Text Key: 318657667
• Report Number: 1018233-2023-04931
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741025235
• UDI-Public: (01)00801741025235
• 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,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: Z097FO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• 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