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

Lot Number JUSCF110

Device Problems Break (1069); 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.The device was not returned.

Event Description

It was reported that the statlock broke off of the patient.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required due to the unknown product code.Therefore, bd was unable to determine the associated labeling to review.Although the product code is unknown, the intermittent catheter labeling was 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 statlock broke off of the patient.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STALOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8477841
• MDR Text Key: 140907258
• Report Number: 1018233-2019-01674
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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
• Device Expiration Date: 04/28/2021
• Device Lot Number: JUSCF110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1