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

Catalog Number UNKNOWN

Device Problems Incorrect Measurement (1383); Fitting Problem (2183)

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

Event Date 04/20/2021

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 5 statlocks from medline were too small to hook a foley catheter.Per follow-up sent on 13may2021, the information currently stated that the statlock was being used with a latex catheter.

Event Description

It was reported that 5 statlocks from medline were too small to hook a foley catheter.Per follow-up sent on 13may2021, the information currently stated that the statlock was being used with a latex catheter.

Manufacturer Narrative

The reported event is inconclusive.Visual evaluation noted one photo sample received.Visual inspection noted two opened statlocks.The clamps appear to be different sizes from the photo, however without an indication of the product code(s), the investigation could not be confirmed.Although an exact root cause could not be determined, a potential root cause is incorrect snap fit.Unable to perform a dhr review since the lot number was not provided.A labeling review was not performed as the lot number and product code are unknown.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.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11837764
• MDR Text Key: 251131441
• Report Number: 1018233-2021-02848
• 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: 08/02/2021

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other