MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Catalog Number	DI0120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2016
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 juapf372 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when making statlock changes, in the first change, the white clip didn't open and required force with scissors and forceps to open it jeopardizing the integrity of the patient and damaging the catheter.In the other changes, the clip didn't close properly.On 11/22/2016 - during investigation, it was discovered that the statlock door opened spontaneous when touched but without engaging the release button.

• Brand Name: STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID
• 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: 6175926
• Report Number: 3006260740-2016-00666
• Device Sequence Number: 993856
• Product Code: KMK
• UDI-Device Identifier: 00801741081637
• UDI-Public: (01)00801741081637(17)190131(10)JUAPF372
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 10/20/2016

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 Expiration Date: 01/31/2019
• Device Catalogue Number: DI0120
• Device Lot Number: JUAPF372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1