MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7711700
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
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) review is not possible, as no manufacturing lot number has been provided by the complainant.Device, not yet returned.
Event or Problem Description
It was reported that during care and maintenance process the nurse found the catheter was completely displaced, but the dacron part was still inside the patient.
Additional Manufacturer Narrative
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 of a cuff detachment was confirmed and the cause was determined to be use related.One 7fr s/l groshong catheter was returned for investigation.The stylet had been removed from the catheter and the connector and oversleeve had been attached to the tubing.The cuff was not attached to the catheter and was not returned for investigation.A microscopic examination of the catheter revealed adhesive attached to the catheter at the 24cm depth mark.The cuff weave pattern was visible in the adhesive that remained on the catheter.A tactual investigation revealed elastic weakness in the 7 fr tubing between the 24 and 26 cm depth marks, which indicates that the catheter was stretched in the area of the cuff.The ifu indicates to not use the catheter if there is any evidence of mechanical damage.The condition of the returned sample indicates that the product was used.The ifu cautions that the catheter must not be forced during tunneling.The ifu states, ¿gently holding the catheter distal to the cuff while pulling the tunneler and catheter through subcutaneous tunnel should result in smooth passage of the cuff(s) through the subcutaneous tunnel.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that during care and maintenance process the nurse found the catheter was completely displaced, but the dacron part was still inside the patient.

• Brand Name: GROSHONG 7 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF
• 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: 7020819
• Report Number: 3006260740-2017-02003
• Device Sequence Number: 18861529
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7711700
• Device Catalogue Number: 7711700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR