MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR PEDIATRIC LENGTH DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600320
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
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 hubs2562 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was loose and ruptured and noted to be cracked at the y-site.No patient injury 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 break in the catheter was confirmed, but without a complete sample, the exact cause was undetermined.One 9fr d/l hickman catheter was returned for investigation.The section of tubing distal to the bifurcation was not returned for investigation.The catheter broke approximately 6mm within the distal end of the bifurcation.A microscopic examination of the break revealed an uneven surface.It was reported that the patient was (b)(6).It is possible that the catheter broke during use from pulling on it; however, without the distal catheter segment, the exact cause was not determined.The broviac catheter should be secured out of sight for infants and children.Vests and other clothing should be used to completely cover tubing and exit site.Patients should not be allowed to pull on tubing at any time to avoid catheter damage or breakage.The sample was forwarded to the manufacturing facility for further review.A lot history review (lhr) of hubs2562 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was loose and ruptured and noted to be cracked at the y-site.No patient injury reported.

• Brand Name: HICKMAN 9 FR PEDIATRIC LENGTH DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7267949
• Report Number: 3006260740-2018-00191
• Device Sequence Number: 16706488
• Product Code: LJS
• UDI-Device Identifier: 00801741051746
• UDI-Public: (01)00801741051746
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: 0600320
• Device Catalogue Number: 0600320
• Device Lot Number: HUBS2562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR