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

Catalog Number PIC0220

Device Problems Misconnection (1399); Material Twisted/Bent (2981)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juew3276 showed seven other similar product complaint(s) from this lot number.

Event Description

It was reported that seven statlock securement clips didn't close properly.No other information was provided.This report addresses the third of seven devices.

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, 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 a damaged statlock device was confirmed.The products returned for evaluation were six picc plus statlock devices with tricot pads and adjustable posts in open packages.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: attempts to test the functionality of the locks were unsuccessful and the latches were observed to be misaligned with the catch base the tab hinges exhibited an off-axis crease and contained damage outside the hinge crease the upper left tab latch of each sample was observed to be bent and/or broken and some had plastic deformation which was seen at the point of contact with the catch some of 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 latches and their 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 tab 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 seven statlock securement clips didn't close properly.No other information was provided.This report addresses the third of seven devices.

• Brand Name: STATLOCK PICC PLUS CRESCENT 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: 11813420
• MDR Text Key: 250242322
• Report Number: 3006260740-2021-01795
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0220
• Device Lot Number: JUEW3276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other