MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Catalog Number VPPDFP

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

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 be evaluated.Results are expected soon.A lot history review (lhr) of jubux364 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the adhesive on the statlock is not holding.Complainant alleged the adhesive would not last a full day.

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 that the adhesive backing was not holding was inconclusive since the original complaint sample was not returned for investigation.One picc statlock stabilization device was returned for investigation with packaging from lot #jubux364.The expiration date was 2020-06-28.The returned statlock revealed no evidence that the paper backing had been removed from the adhesive substrate.After removing the paper backing, the surface of the adhesive substrate was noted to be glossy.The returned device was compared to an unused statlock device.The unused device exhibited a similar glossy adhesive surface.A tactual investigation revealed that the tack of the complaint sample was similar to the tack of the unused device.The complaint sample was adhered to the inside surface of the tyvek sheet from the packaging.An unused device was also adhered to the tyvek sheet and the retentions properties of the substrates were similar and revealed nothing remarkable.Since the original sample was not returned, the complaint was inconclusive.The product ifu states, ¿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.¿ the ifu indicates to remove oil and moisturizer from targeted skin area.The ifu also states, ¿prepare targeted statlock® stabilization device area using alcohol, to remove oil and moisture, and skin prep for skin protection and enchanced adhesion.Allow to dry completely as contact with alcohol can weaken bonding of components and pad adherence.Always connect statlock® stabilization device to catheter before adhering pad to skin.¿ a lot history review (lhr) of jubux364 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the adhesive on the statlock is not holding.Complainant alleged the adhesive would not last a full day.No patient injury was reported.

• Brand Name: STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7279092
• MDR Text Key: 100480564
• Report Number: 3006260740-2018-00238
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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: Lay User/Patient
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: VPPDFP
• Device Lot Number: JUBUX364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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