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

Catalog Number STATLOCK DEVICE

Device Problem Inadequate or Insufficient Training (1643)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the statlock seemed to turn and caused the foley to loop, which led to tension and pull on the catheter, and this resulted in stopping the urine flow.It was also stated that the clip was confusing on how to get it opened.The statlock was placed 10 days ago, but the problem began only two days back.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " poor label printing".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.The product catalog number and the lot number for this device are 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 statlock seemed to turn and caused the foley to loop, which led to tension and pull on the catheter, and this resulted in stopping the urine flow.It was also stated that the clip was confusing on how to get it opened.The statlock was placed 10 days ago, but the problem began only two days back.

• Brand Name: STATLOCK SL FOLEY
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12217251
• MDR Text Key: 263125283
• Report Number: 1018233-2021-04422
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: STATLOCK DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other