MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Catalog Number	DI0120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2016
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: visual observation showed 1 sl statlock stabilization device with tricot pad returned.The sample was stuck to its tyvek pouch label.It was not in unopened packaging.Some residue was found on the pad.Functional testing showed the following: the sample did not show significant problems maintaining the clamp closed, and would open without difficulty upon application of pressure.When checking for excess adhesive under the lips into which the prongs lock, some such adhesive was noted under the lip on the right, when the device was oriented such that the text on the pad could be read.Microscopic evaluation showed no more than minor damage on the lips and prongs of the device¿s locking mechanism.Although adhesive was found in the gap underneath one lip, and adhesive has the capacity to interfere with the locking mechanism, other factors may also have contributed to this event.For instance, little is known about the conditions of use except that the original complaint stated that a device was used with a hemodialysis catheter, but rough and repeated use, or use with catheters incompatible with the device (e.G., too large) may also result in wear and difficulty of use.Due to the presence of the adhesive under the lip of the retention device, confirmed by manufacturing review, and given unknown procedural circumstances, the complaint is confirmed.A lot history review (lhr) of juzhf084 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after the nurse placed the statlock to the hemodialysis catheter on the patient, it allegedly popped open minutes later.The nurse placed a new statlock and it worked ok.
Additional Manufacturer Narrative
The initial mdr indicated the reportable date of awareness as (b)(6) 2016 this information was erroneous, the actual reportable date of awareness is (b)(6) 2016.

• Brand Name: STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD
• 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: 5889693
• Report Number: 3006260740-2016-00445
• Device Sequence Number: 16239514
• Product Code: KMK
• UDI-Device Identifier: 00801741081637
• UDI-Public: (01)00801741081637(17)180731(10)JUZHFO84
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 07/31/2018
• Device Catalogue Number: DI0120
• Device Lot Number: JUZHF084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2016
• Supplement Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1