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

Catalog Number PIC0220CE

Device Problem Misconnection (1399)

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

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, returned physical samples, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty closing the statlock latch was confirmed and the cause was determined to be use related.The product returned for evaluation was two statlock picc plus catheter securement devices.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 samples were evaluated and the following observations were made which were consistent with this failure type: an attempt to test the functionality of the lock was unsuccessful and the two top right latches were observed to be misaligned with the catch base the associated right tab hinges exhibited an off-axis crease and contained damage outside the hinge crease the tab latches were observed to be bent and had plastic deformation which was seen at the point of contact with the catch the tab catches exhibited plastic deformation at the point of contact with the latch 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 their points 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 doors 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.A lot history review (lhr) of jues2195 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (jues2195) have been reported from the same facility in the (b)(4).

Event Description

It was reported the statlock clips open.No other information was provided.Two devices were returned.This report addresses the second device.

• Brand Name: STATLOCK SLIDING POST CRESCENT PAD SKIN PREP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12049797
• MDR Text Key: 257762224
• Report Number: 3006260740-2021-02402
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0220CE
• Device Lot Number: JUES2195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other