MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BA; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7755305
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezj1831 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc had a hole prior to use.No patient injury was reported.
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 in the catheter was confirmed and the cause was determined to be use related.One 3 fr groshong picc was returned for investigation.The groshong catheter was received with the stylet in the lumen.It was noted that the stylet had been repositioned within the catheter.The catheter tubing had been advanced over the metal cannula and was abutting the distal end of the white connector.Blood residue was visible within the catheter, which indicates that the product was in use.A functional test revealed a leak 2.1cm from the distal tip of the catheter.The leak site revealed a circular hole in the clear portion of the tubing that coincided with the distal tip of the stylet.It appears that the stylet was pushed through the catheter wall.The ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Avoid perforating, tearing or fracturing the catheter when using a guidewire.Do not use the catheter if there is any evidence of mechanical damage or leaking.¿.
Event or Problem Description
It was reported that the picc had a hole prior to use.No patient injury was reported.

• Brand Name: GROSHONG 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BA
• 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: 6544187
• Report Number: 3006260740-2017-00567
• Device Sequence Number: 13769698
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757(17)181028(10)REZJ1831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: Other
• Device Expiration Date: 10/28/2018
• Device Model Number: 7755305
• Device Catalogue Number: 7755305
• Device Lot Number: REZJ1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1