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

Catalog Number	7711800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 of a break in the catheter was confirmed, and the cause appears to be related to use of the device.The proximal segment of an 8fr groshong catheter was returned for investigation.It was reported that the catheter ¿fell apart¿ upon removal.The catheter broke under the surecuff.Adhesive that matched the weave pattern of the surecuff was observed at the distal end of the catheter segment.The cuff and the distal catheter segment were not returned for investigation.Small superficial slits were observed in the catheter 3mm from the distal tip of the catheter segment, which coincided with the proximal end of the cuff adhesive.The catheter may have been inadvertently nicked with a scalpel during removal.It is possible that the break in the tubing initiated from an inadvertent nick coupled with traction.The ifu indicates to take care not to transect the catheter during removal and cautions, ¿do not grasp the catheter with any instrument that might sever or damage the catheter.¿ a lot history review (lhr) of reay0032 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the catheter "fell apart" upon removal.No other information was known but has been requested.No patient injury was reported.

• Brand Name: GROSHONG 8 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: 6606228
• Report Number: 3006260740-2017-00697
• Device Sequence Number: 10841988
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743(17)211031(10)REAY0032
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 06/01/2017

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: 10/31/2021
• Device Catalogue Number: 7711800
• Device Lot Number: REAY0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1