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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

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.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.The device was not returned.

Event Description

It was reported that the statlock clip disconnected from the adhesive pad.

Event Description

It was reported that the statlock clip disconnected from the adhesive pad.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the foley statlock product ifus are found to be adequate based on past reviews.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.

• 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: 7754438
• MDR Text Key: 116463989
• Report Number: 1018233-2018-03407
• Device Sequence Number: 0
• Product Code: EYJ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1