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

Model Number N/A

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jucxf391 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported when the product was opened it was "verified that the sticking was not adhering, making it impossible to use." device was not used on a patient.

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 ¿the sticking was not adhering¿ is inconclusive due to the state of the returned sample and the uncertainty in the event description.One picc plus statlock kit was returned for evaluation.An initial visual observation showed the kit was returned open with all of the kit components returned within.The skin prep pad packet within the kit was also returned open and the skin prep pad was returned outside of the packet.The skin prep pad was observed to be crumpled, dry, and stiff.The interior of the skin prep pad packet was found to be stuck to itself with a residue on the clear film of the packet.Many creases and wrinkles were observed in the packet, and when a bright light was directed into the open packet, light could be seen shining through several holes and/or tears in the packet.A microscopic observation revealed a small tear in the packet at one of the locations the light was seen to shine through.One of the liners on the back of the statlock device was observed to be folded over itself exposing the adhesive on the back of the statlock pad.This exposed adhesive was found to be still sticky and the adhesive underneath the liner was also found to be sticky.While the description of the reported event is somewhat unclear, the returned skin prep pad was found to be dry; however, the condition the packet was returned in made it difficult to determine if the packet was damaged during storage, handling, or use or if the pad was dry due to insufficient solution application during manufacture.Therefore, this complaint is inconclusive at this time.

Event Description

It was reported when the product was opened it was "verified that the sticking was not adhering, making it impossible to use." device was not used on a patient.

• 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: 9179875
• MDR Text Key: 162003990
• Report Number: 3006260740-2019-02975
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: VPPCSP
• Device Lot Number: JUCXF391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1