MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 45 CM 5 FR. D/L GROSHONG NXT BASIC WITH MI AND TLS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9857505
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2016
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reas2386 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc was inserted (b)(6) 2016 in the left basilic vein (inserted 44 cm and 2.5 cm on skin).It was reported that on (b)(6) 2016 the picc was leaking fluid out of insertion site.The line was pulled back and a hole was allegedly found in the line at around 43.5 cm.This hole was inside the patient.No patient injury reported.
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, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 5fr d/l groshong catheter.Light usage residues were observed within the sample.A small split was observed between the 43cm and 44cm depth markings.An attempt to infuse water through the sample using a 12ml syringe revealed the red-luered lumen to be patent to infusion and aspiration with no observed leaks.The white lumen was found patent; however, a leak was observed emanating from the site of the aforementioned split.The sample kinked preferentially in the vicinity of the split during manual manipulation.Microscopic inspection split revealed sharply defined irregular fracture edges.The split exhibited a branched shape.Catheter surface abrasion was observed in the vicinity of the split.The surface abrasion, sharply defined edges and highly irregular split edges were typical of damage initiated by contact with a traumatic instrument.The product ifu states ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿.
Event or Problem Description
On (b)(6) 2017 - additional information reported by facility: no securacath was used on the patient.The nurse reported the line had been in place for about a week with no issues, but then noticed the leak when she went to administer the chemo.

• Brand Name: 45 CM 5 FR. D/L GROSHONG NXT BASIC WITH MI AND TLS
• 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: 6119244
• Report Number: 3006260740-2016-00618
• Device Sequence Number: 19067033
• Product Code: FOZ
• UDI-Device Identifier: 00801741036163
• UDI-Public: (01)00801741036163(17)180531(10)REAS2386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2016

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: 05/31/2018
• Device Catalogue Number: 9857505
• Device Lot Number: REAS2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1