MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV ULTRA DUAL POSTED TRICOT PAD, TETHERED LOCKING CAPS. 25 BOX; STAND, INFUSION

Catalog Number	CV0321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 of statlock retention device separation from the pad substrate was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs depicting a statlock cv ultra dual post catheter stabilization device.The depicted device was attached to a hemo-flow dialysis catheter.The retainer portion of the device was completely detached from the tricot substrate pad.The substrate pad exhibited material discoloration.Inspection of the submitted photographs confirmed detachment of the retainer from the pad, inspection of the photographs was insufficient to identify the cause of the detachment.Potential contributing factors include chemical degradation of the adhesive and insufficient adhesive application.A lot history review (lhr) of judsf496 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that it has occurred for the 2nd time in two different patients that the fixation member releases from the fixation patch.The patch was on the patient's photo, placed on tuesday.The photo shows what the nurse found four days later.Patient has not been in the shower with the patch.This patch is very important for the fixation of (not yet ingrown) tunneled central venous catheters.Releasing has a significant risk of dislocation and infection.This report addresses the 2nd patient.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.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 of statlock retention device separation from the pad substrate was confirmed; however, the root cause was not identified.Two photographs depicting a statlock cv ultra dual post catheter stabilization device were returned for investigation.The depicted device was attached to a hemo-flow (non-vad) dialysis catheter.The retainer portion of the device was completely detached from the tricot substrate pad.The substrate pad exhibited material discoloration.Inspection of the submitted photographs confirmed detachment of the retainer from the pad, but the cause of the detachment could not be determined from the photographs.An unused same lot sample was subsequently returned.A visual observation of the unused sample revealed that the retainer was adhered to the substrate.The adhesive extended to the perimeter of the retainer base.After forcefully removing the retainer from the substrate, a microscopic examination revealed variation in adhesive coverage near the center of the retainer.The manufacturing facility was notified of this complaint.There were no changes in the manufacturing process and quality inspections revealed no issues associated with the reported lot.Potential contributing factors include chemical degradation of the adhesive, patient induced damage, and insufficient adhesive application of the affected part.A lot history review (lhr) of judsf496 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in the netherlands.
Event or Problem Description
It was reported that it has occurred for the 2nd time in two different patients that the fixation member releases from the fixation patch.The patch was on the patient's photo, placed on tuesday.The photo shows what the nurse found four days later.Patient has not been in the shower with the patch.This patch is very important for the fixation of (not yet ingrown) tunneled central venous catheters.Releasing has a significant risk of dislocation and infection.This report addresses the 2nd patient.

• Brand Name: STATLOCK CV ULTRA DUAL POSTED TRICOT PAD, TETHERED LOCKING CAPS. 25 BOX
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9655049
• Report Number: 3006260740-2020-00354
• Device Sequence Number: 1877991
• Product Code: FOX
• UDI-Device Identifier: 00801741081576
• UDI-Public: (01)00801741081576
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 04/28/2022
• Device Catalogue Number: CV0321
• Device Lot Number: JUDSF496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1