MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3 FR SINGLE LUMEN, BASIC TRAY WITH MI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	9755305
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 rebq1094 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the catheter leaked during pre-flush.Leak was noted close to the distal end of the catheter.Device was not used on a 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 leak was confirmed, and the damage appeared to be use related.One 3fr groshong picc was returned for investigation.The picc was received with the tls stylet in the lumen.The red hang tag was still attached to the stylet.It appeared that the stylet had been had been retracted through the t-lock extension set.The distal tip of the stylet was positioned 2.7cm from the proximal end of the valve slit, which indicates that the stylet had been retracted approximately 2cm from the manufactured position.A functional test confirmed a fluid leak at the 14 and 15 cm depth marks.A microscopic examination of the leak site revealed longitudinal splits in the blue stripe.Longitudinal splits were also observed in the clear portion of the tubing approximately 180-degrees from the splits in the blue stripe.The catheter was cut longitudinally to examine the leak site from within the catheter, which revealed a longer split on the internal surface of the tubing.Scuff marks were observed adjacent to the splits in the blue stripe.The greater extent of damage on the inner lumen wall indicated that the catheter was damaged from within.The observed damage is consistent with the tubing being damaged by the stylet.This type of damage can occur if the catheter is compressed over the stylet or if the stylet is forcefully removed from the picc.The product ifu cautions, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.¿ one of the precautions in the ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿.
Event or Problem Description
Facility reported to the sales rep that the catheter leaked during pre-flush.Leak was noted close to the distal end of the catheter.Device was not used on a patient.

• Brand Name: GROSHONG 3 FR SINGLE LUMEN, BASIC TRAY WITH MI
• 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: 6864955
• Report Number: 3006260740-2017-01589
• Device Sequence Number: 1183277
• Product Code: LJS
• UDI-Device Identifier: 00801741036064
• UDI-Public: (01)00801741036064
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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 Model Number: 9755305
• Device Catalogue Number: 9755305
• Device Lot Number: REBN0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1