MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600574
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
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 for evaluation, as the device remains in the patient.A lot history review (lhr) of huzh2094 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported that the white lumen had a pinhole at hub of line.Facility also reported that the outer layer had separated above the triangle area where the lumens meet.Required dual repair.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, 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 pinhole in the catheter near the hub was confirmed, and the damage appears to be use related.The external segment of a hickman 7fr d/l catheter was returned for investigation.The d/l catheter tubing extended 1.8cm from the distal end of the bifurcation.The remainder of the catheter was not returned for investigation.A visual observation of the returned sample revealed evidence of use.The printing was completely worn from the clamping oversleeves.Debris was observed in the crevices of the clamps.Two holes were observed in the clamping oversleeve 3mm from the distal end of the white crimp collar.The holes were 180-degrees apart.A functional test revealed that fluid would leak from the holes when the lumen was pressurized.Due to the evidence of use found on the returned catheter, this was considered a use related issue.The holes most likely developed after placement.The observed damage can occur if the clamp is compressed over the catheter adjacent to the crimp collar.The catheter should always be clamped over the reinforced clamping sleeve, but never over the section of tubing directly adjacent to the connector.
Event or Problem Description
Facility reported that the white lumen had a pinhole at hub of line.Facility also reported that the outer layer had separated above the triangle area where the lumens meet.Required dual repair.No patient injury reported.

• Brand Name: HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS
• 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: 6356844
• Report Number: 3006260740-2017-00153
• Device Sequence Number: 13759578
• Product Code: LJS
• UDI-Device Identifier: 00801741051876
• UDI-Public: (01)00801741051876(17)200928(10)HUZH2094
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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: 09/28/2020
• Device Catalogue Number: 0600574
• Device Lot Number: HUZH2094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• 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: 02/24/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1