MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problem Mechanics Altered (2984)

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

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 of ¿catheter malfunctioned¿ was confirmed and the cause was use-related.The product returned for evaluation was three photographs which depicted a placed groshong central venous catheter.Each photograph depicted the proximal end of the device extending from the insertion site.The insertion site was dressed with a biopatch disk and an adhesive dressing.Blood residue was observed within the portion of visible catheter.The inlaid stylet was in place and a needleless injection cap was attached to the stylet flushing connector.The submitted photographs depicted a placed catheter wherein the stylet was not removed and the flushing connector was not properly assembled.The product ifu states ¿warning: do not leave stylet in catheter.¿ the ifu provides instructions and images describing proper assembly of the catheter connector.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the facility that the 7 fr groshong catheter malfunctioned.No other information was provided, but has been requested.On (b)(6) 2017-photo provided shows stylet was not removed and luer lock incorrectly attached to catheter.

• Brand Name: GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7054233
• MDR Text Key: 93577658
• Report Number: 3006260740-2017-02123
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/22/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7711700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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