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	12/15/2016
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 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, but the exact cause is unknown.An 8 fr groshong single-lumen catheter was returned for investigation.The catheter was received with the stylet in the lumen.The stylet was bent 9.2cm and 15.7cm from the distal end of the metal cannula.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 detached during placement, but the root cause of the separation is inconclusive.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.A lot history review (lhr) of reau1270 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by facility that when inserting a groshong cv catheter, the white cuff on the catheter was said to not be permanently attached and slid up and down the catheter.Another catheter was used to complete the procedure.No patient injury reported.

• 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: 6284616
• Report Number: 3006260740-2017-00030
• Device Sequence Number: 18998574
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767(17)210628(10)REAU1270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2017
• Report Date (Section F): 01/05/2017

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: 06/28/2021
• Device Catalogue Number: 7711804
• Device Lot Number: REAU1270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 95
• Date Report Sent to FDA: 01/05/2017