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

Model Number N/A

Device Problem Misconnection (1399)

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

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached retainer is confirmed and was determined to be manufacturing related.Thirty-one sealed picc plus statlock kits, one open picc plus statlock kit, one fully detached retainer from a picc plus statlock device, and two fully detached pads from picc plus statlock devices were returned for evaluation.An initial visual observation showed one of the pads was returned without a liner, and use residue was observed on both pads.A microscopic observation revealed poor adhesive coverage and what appears to be some adhesive that was not fully cured on the underside of the single fully detached retainer.Each of the sealed kits were open and the statlock devices within were examined.At least one corner and/or side of the retainer of twelve of these samples was found to begin to detach from the pad with little force.Some strings of what is likely uncured adhesive were observed between the pad and the retainer of some of these samples.This investigation has been forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) of judy2477 showed 13 other similar product complaint(s) from this lot number.The complaints for this lot number (judy2477) have been reported from the same facility in the (b)(4).

Event Description

It was reported that a patient came in with a broken fixation plaster.No other information was provided.(b)(6) 2021- fourteen devices were confirmed to be detached.This report addresses the 11th device.

• Brand Name: STATLOCK SLIDING POST TRICOT 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
• 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: 11732605
• MDR Text Key: 247595392
• Report Number: 3006260740-2021-80044
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741082955
• UDI-Public: (01)00801741082955
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: PIC0220CE
• Device Lot Number: JUDY2477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• 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