MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK UNIVERAL PLUS MEDIUM CLAMP ON UNIVERSAL PAD, INCLUDES SKIN PREP; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	N/A
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jubwf424 showed no other similar product complaint(s) from this lot number.: mw5074762.
Event or Problem Description
It was reported that the patient required a bilateral chest tube for bilateral pleural effusions.The catheters that were used for thoracentesis were secured with a statlock.On the right side under the statlock patient had developed an unstageable pressure injury.Upon inspection of the left side patient was noted to be in normal condition.

• Brand Name: STATLOCK UNIVERAL PLUS MEDIUM CLAMP ON UNIVERSAL PAD, INCLUDES SKIN PREP
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7336805
• Report Number: 3006260740-2018-00432
• Device Sequence Number: 1722800
• Product Code: KMK
• UDI-Device Identifier: 00801741083426
• UDI-Public: (01)00801741083426
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VUPD1012
• Device Lot Number: JUBWF424
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial 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