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

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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 foley statlock clip came off.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to "glue selection incompatible with clamp base".The device used for treatment, though it was unknown whether the device was related to the reported event or met specifications.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product family for this foley statlock product was unknown.Therefore, bd was unable to determine the associated labeling to review.Although the product family was unknown, the (foley statlock product) ifu's are found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the foley statlock clip came off.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10147761
• MDR Text Key: 195377296
• Report Number: 1018233-2020-03774
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1