MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX; STAND, INFUSION

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a plastic retainer disconnection was confirmed but the exact cause remains unknown.Four cv plus statlock securement devices were returned for investigation.One package was returned and contained product information lot: judy2115.The plastic retainer portions on the four devices were returned completely separated from the dressing pad.Evidence of use was visible on each of the returned samples.Tactile evaluation of the adhering surfaces showed adhesive to be present on all four samples.Microscopic observation of the samples revealed adhesive to be present between the retainer base and the pad contact surfaces.A review of the manufacturing and device history records (dhr) did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Based on the condition of the returned samples, possible contributing factors include adhesive weakening due to antiseptic or cleaning solutions and forces applied during use.The product instructions for use (ifu) precautions state, "do not use the statlock device where loss of adherence could occur, such as with a confused patient, diaphoretic or nonadherent skin, or when the access device is not monitored daily" and "avoid contact with alcohol or acetone, both can weaken bonding of components and the statlock pad adherence." a lot history review (lhr) of judy2115 showed six other similar product complaint(s) from this lot number.The complaints for this lot number (judy2115) have been reported from the same facility in (b)(6).

Event Description

It was reported that there has been an increase in the number of safety reports related to the plastic piece of the statlock detaching from the adhesive backing.No other information was provided.It was further reported that this occurred with 7 devices, four of which were returned to manufacturer.This report addresses the fourth device.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 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 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10907028
• MDR Text Key: 218725457
• Report Number: 3006260740-2020-03589
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741081552
• UDI-Public: (01)00801741081552
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: N/A
• Device Catalogue Number: CV0226
• Device Lot Number: JUDY2115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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