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	10/12/2016
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of juatf782 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Nurse reported that the user changed the statlock and that it clipped on correctly.Report continued stating that by the end of dialysis treatment, the statlock had allegedly popped open would not re-clip.No patient injury reported.
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: the complaint that the statlock device is popping open could be related to an inadvertent application of adhesive in the locking area of this unit during the manufacturing process.Two statlock devices were returned for investigation.A visual observation of the returned statlock devices revealed that the adhesive backing had been removed from sample #1, which indicates that the product had been used.Sample #2 appeared to be unused.A functional test revealed that each retainer had some retention force, but could be opened without pushing in on the button to unlock the locking arms.A microscopic examination of the samples revealed adhesive under the edge of the locking arm retainer, which would prevent the barbs on the locking arm from sliding underneath the edge.The tips of the locking barbs exhibited deformation, and it appears to be related to the adhesive that prevented proper locking of the retainer.Patient movement or the position/type of device in the retainer may also affect the retention properties.

• 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: 6080842
• Report Number: 3006260740-2016-00585
• Device Sequence Number: 16333010
• Product Code: KMK
• UDI-Device Identifier: 00801741081637
• UDI-Public: (01)00801741081637(17)190531(10)JUATF782
• 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: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2016

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: 05/31/2019
• Device Catalogue Number: DI0120
• Device Lot Number: JUATF782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1