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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional 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 jubrf055 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the adhesion site on the statlock was not sticky.No other information was provided.
Additional 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 substrate was not sticky was inconclusive due to the sample condition.One picc statlock stabilization device was returned for investigation.The returned statlock revealed that the paper backing had been removed from the adhesive substrate and reapplied to the adhesive.After removing the paper backing, the surface of the adhesive substrate was observed to be dull with small areas of a glossy surface.The returned device was compared to an unused statlock device.The unused device exhibited a glossy adhesive surface and increased tack.It appeared that the returned device had been previously applied to a surface before it was returned for investigation.Since the returned device exhibited evidence of use, the original condition of the adhesive substrate was unknown.Whether the skin was properly prepped, which would affect the retention properties of the adhesive substrate, was unknown.A lot history review (lhr) of jubrf055 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the adhesion site on the statlock was not sticky.No other information was provided.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7187670
• Report Number: 3006260740-2017-02423
• Device Sequence Number: 1952101
• Product Code: KMK
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUBRF055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1