MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN STATLOCK DEVICE

Device Problem Disconnection (1171)

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

Event Date 01/30/2023

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 after turning patient in bed, patients foley catheter was noted to be out from the foley statlock.When staff was about to reattach the foley balloon port or urine drainage port to the statlock noticed that the balloon port was severed and soon right after the catheter then slipped out of patient¿s penis and balloon was already deflated.Patient was not injured while this incident occurred.Stated that the staff heard in tier 4 this morning that there were also reports of the drainage bag emptying very slowly.This sounds like an air filter problem to them.

Manufacturer Narrative

The reported event was inconclusive since sample condition was poor.It is unknown whether the device had met relevant specifications.The product was used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with an inlet tube and sample port connector.Visual inspection of the sample noted the inflation arm/valve cap disconnected from the catheter and the foley statlock could not be evaluated since sample condition was poor, therefore this investigation is considered inconclusive.Flushed the sample port and filled the drainage bag with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no issues were observed from the drainage bag.A potential root cause for this failure mode could be ¿inappropriate snap fit".Based on information in the fmea, the residual risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.The lot number is unknown; therefore, the device history record could not be reviewed.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 actual/suspected device was inspected.

Event Description

It was reported that after turning patient in bed, patients foley catheter was noted to be out from the foley statlock.When staff was about to reattach the foley balloon port or urine drainage port to the statlock noticed that the balloon port was severed and soon right after the catheter then slipped out of patient¿s penis and balloon was already deflated.Patient was not injured while this incident occurred.Stated that the staff heard in tier 4 this morning that there were also reports of the drainage bag emptying very slowly.This sounds like an air filter problem to them.

• Brand Name: UNKNOWN STATLOCK DEVICE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16403742
• MDR Text Key: 309892676
• Report Number: 1018233-2023-01003
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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