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

Catalog Number DI0120CE

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2016

Event Type  malfunction  

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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the statlock device is opening could be related to an inadvertent application of adhesive in the locking area of this unit during the manufacturing process.One statlock device was returned for investigation.The paper backing was attached to the adhesive substrate.The locking arms were disengaged from the retainer and a microscopic examination of the sample revealed adhesive under the edge of the locking arm retainer on one side of the statlock device.The adhesive prevented the locking barb from sliding completely under the locking edge of the retainer.The tips of the locking barbs exhibited plastic deformation, which is most likely caused by the premature opening of the retainer.A functional test revealed that the retainer had some retention force, but could be opened without unlocking the locking arms.Patient movement or the position/type of device in the retainer may also affect the retention properties.A lot history review (lhr) of juapf373 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the plastic holders of the statlock dialysis stabilization devices go on easily but have allegedly sprung open by themselves.Facility reported that after implantation of a catheter, they used a statlock dialysis stabilization device to affix the catheter.They reported that the statlock "lock" did hold the catheter but then popped open allowing the dialysis catheter to "fall out".No patient injury reported.

• Brand Name: STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5883284
• MDR Text Key: 53119065
• Report Number: 3006260740-2016-00430
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00801741081644
• UDI-Public: (01)00801741081644(17)190131(10)JUAPF373
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: DI0120CE
• Device Lot Number: JUAPF373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1