MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP; STAND, INFUSION

Model Number N/A

Device Problem Misconnection (1399)

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

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty to close is confirmed but the exact cause could not be clearly determined from the photo provided.One photo sample of a statlock securement device was provided for investigation.The statlock appears to be adhered to a white piece of paper.Both doors are shown to be open.The right-side door appears to be bent at an angle which may cause issues during the closing of the door.The characteristics of the hinge, locking bards, and retainer cannot be clearly observed.The door was observed to be bent at an angle which suggest that a force was applied at an off angle to the door hinge which may have contributed event; however, since the characteristics of the device component could not be clearly observed, the exact cause remains unknown.A lot history review (lhr) of judsf399 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the device presented difficulty during its closure.No other information was provided.

Event Description

It was reported that the device presented difficulty during its closure.No other information was provided.

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, 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 and the cause was determined to be use related.The product returned for evaluation was one picc plus statlock with a foam 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: an attempt to test the functionality of the lock was unsuccessful and the latches were observed to be misaligned with the catch base the tab hinge exhibited an off-axis crease and contained damage outside the hinge crease the tab latch was observed to be bent and had plastic deformation which was seen at the point of contact with the catch the tab catch exhibited plastic deformation at the point of contact with the latch use residue was seen on the sample which indicated that the device had undergone at least some use.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.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9916789
• MDR Text Key: 194794263
• Report Number: 3006260740-2020-01142
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUDSF399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Event Location: Hospital
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1