MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECU; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7711804
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaw0771 showed one other similar product complaint from this lot number.
Event or Problem Description
Facility reported to the sales rep that during the procedure the nurse was pulling the tunneler and noted that the cuff was not attached to the catheter.The procedure was stopped, catheter was removed and a dual lumen groshong catheter was placed.No patient injury was 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, frequency 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 cuff detached from the catheter was confirmed, and the cause appears to be use related.An 8 fr groshong single-lumen catheter was returned for investigation.The catheter was received without the stylet.The overall length of the catheter was 51.5cm.The surecuff was received separate from the catheter.A microscopic examination of the cuff revealed nothing remarkable.Adhesive remained attached to the catheter at the 24cm depth mark.The pattern from the cuff weave was visible in the adhesive that remained on the catheter, which indicates that the cuff had been adhered to the tubing.A tactual investigation revealed elastic weakness in the 8 fr tubing between the 23 and 27 cm depth marks, which indicates that the catheter was stretched in the area of the cuff.A functional test revealed that the catheter was patent to infusion and no leaks were observed.It was reported that the cuff detachment was observed after pulling the catheter through the tunnel.The ifu indicates to not use the catheter if there is any evidence of mechanical damage.The ifu also indicates that the catheter must not be forced during insertion.Instructions are provided to provide smooth passage of the cuff through the subcutaneous tunnel.

• Brand Name: GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECU
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6409745
• Report Number: 3006260740-2017-00250
• Device Sequence Number: 18970956
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767(17)210930(10)REAW0771
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 7711804
• Device Lot Number: REAW0771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 121