MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT SLIDING-POST, 50BX; CATHETER SECUREMENT DEVICE

Catalog Number VPPCSPCE

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of juaxf589 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (juaxf589) have been reported from the same (b)(6) facility.

Event Description

It was reported that the achor pad had its adhesive pad detached from its plastic part.The operator tried another kit from the same lot and, this time, the adhesive power of the anchor pad was weak.This file addresses the second pad.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a detachment of the base of a statlock from the foam pad is confirmed, and the cause is determined to be manufacturing-related.The device returned was picc plus statlock device with movable posts.For the purposes of directional references in this investigation, the statlock frame of reference is with the lettering up and arrows pointing away from the viewer.The other (sample 2) still had its adhesive backing and had its base attached only partially, such that the right side was more bound than the left.The device was marked to show where the adherence of the base to the pad began, and the base was then peeled off.On the adherent side of the pad, material was found to be missing, having come away with the base, and on the other, no material was missing, although a clear impression of the base was present.A sample picc plus device was used for comparison.The base was pulled off the pad, which required significant force, and the separated surfaces examined.The outline of the base on the pad was easily visible and marked by missing foam material.One chunk in particular came away on the bottom of the base.It is evident that the statlock device returned did not have a standard coverage of adhesive binding the base to the foam.This resulted in susceptibility to detachment.The device was sent to the manufacturing site for further evaluation.Mfg conclusion: the complaint for retainer weakly attached and detaching from the foam pad has been confirmed per evaluation.The root cause for the reported event is related to manufacturing due to no and poor application of adhesive.A lot history review (lhr) of juaxf589 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (juaxf589) have been reported from the same (b)(6) facility.

Event Description

It was reported that the anchor pad had its adhesive pad detached from its plastic part.The operator tried another kit from the same lot and, this time, the adhesive power of the anchor pad was weak.This file addresses the second pad.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING-POST, 50BX
• Type of Device: CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; parque industrial aeropuerto; warwick RI 02886
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6865228
• MDR Text Key: 86313360
• Report Number: 3006260740-2017-01599
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00801741083372
• UDI-Public: (01)00801741083372
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPPCSPCE
• Device Lot Number: JUAXF589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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