MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP; STAND, INFUSION

Model Number N/A

Device Problems Misconnection (1399); Detachment of Device or Device Component (2907)

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

Event Date 08/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Ansm local authorities informed - "it was reported that : the stat-lock device was installed on (b)(6) 2021.This day, by redoing the picc-line dressing, the device was broken in 2, therefore, the catheter did not stay in place as usual, it came out 1 cm.Consequence: risk of infection and risk of mismatching the central catheter, therefore risk of extravasation treatments.".

Event Description

Ansm local authorities informed - "it was reported that : the stat-lock device was installed on (b)(6) 2021.This day, by redoing the picc-line dressing, the device was broken in 2, therefore, the catheter did not stay in place as usual, it came out 1 cm.Consequence: risk of infection and risk of mismatching the central catheter, therefore risk of extravasation treatments.".

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a detached retainer from the pad is confirmed but the exact cause remains unknown.One statlock securement device was returned for evaluation.The adhesive liners were not present.The retainer was detached from the foam pad.The doors were in a closed position but not locked in place.Microscopic observation of the bottom side of the retainer revealed adhesive to be present throughout the base surface.An impression of the retainer base was present on the foam pad.Tactile evaluation of the adhesive revealed it to be dried and not tacky.Based on the information and sample provided, possible contributing factors include damage during use or handling.Since the retainer was observed to be detached, the complaint is confirmed but the exact contributing factors remain unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12558347
• MDR Text Key: 274240427
• Report Number: 3006260740-2021-04090
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VPPCSPCE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other