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

Device Problems Disconnection (1171); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 statlock would not stay closed.The complainant also stated that they had faced the same issue with three statlocks.

Event Description

It was reported that the statlock would not stay closed.The complainant also stated that they had faced the same issue with three statlocks.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿inappropriate snap fit¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock sl foley product ifus were found to be adequate based on past reviews.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10290095
• MDR Text Key: 199850801
• Report Number: 1018233-2020-04635
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1