MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK CV PLUS SLIDING POST; STAND, INFUSION

Model Number N/A

Device Problems Connection Problem (2900); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of judtf112 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported that the buckle was not engaged firmly.No other information was provided.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the inability to close and lock a statlock device was confirmed.The product returned for evaluation was one cv plus statlock device with a tricot pad and adjustable posts.The investigation findings are consistent with damage caused by pushing the securement tab at an angle while attempting to close the device.This issue can be avoided by centering the thumb about the middle of the tab and pressing directly downwards.The returned product sample was evaluated and the following observations were made which were consistent with this failure type: the tab hinge exhibited an off-axis crease and contained damage outside the hinge crease the tab latch was observed to be bent the tab catch exhibited plastic deformation at the point of contact with the latch an attempt to test the functionality of the lock was unsuccessful and the latches were observed to be misaligned with the catch base this failure type was recreated in the laboratory using non-complainant samples by closing the tab at an angle, or by pressing outside the center of the tab, and the features observed on the laboratory samples were similar to those on the returned complainant sample.The nature of the damage observed on the latch and its point of contact on the catch base, as well as the characteristics of the hinge damage, are evidence that the damage was caused by misalignment of the door when closing the device.Pushing the tab at an angle can cause the latch to miss the catch base and can permanently bend the latch.An examination of the sample revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the buckle was not engaged firmly.No other information was provided.

• Brand Name: STATLOCK CV PLUS SLIDING POST
• 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: 10950316
• MDR Text Key: 220251381
• Report Number: 3006260740-2020-20800
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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 Model Number: N/A
• Device Catalogue Number: CV0220CE
• Device Lot Number: JUDTF112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other