MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
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 hubq0797 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the physician flushed the hickman catheter at the end of the procedure and noticed it to be leaking.The catheter was removed and a new one was placed.There was no harm to the patient 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, but the cause could not be determined due to the request of non-destructive testing.One hickman s/l 9.6fr catheter was returned for investigation.The catheter extended 18.7cm from the distal end of the surecuff.What appeared to be blood residue was observed within the fibers of the cuff.The catheter had been marked with blue ink along the distal end of the clamping oversleeve.A functional test revealed a leak in the clamping oversleeve.The leak site was located 9mm from the distal edge of the clamping oversleeve.A microscopic examination of the leak site revealed a ½ mm c-shaped breach in the tubing.Since non-destructive testing was requested, the catheter was not cut open to observe the breach from within the catheter.With the observed leak, the complaint was confirmed, but the cause of the breach in the tubing could not be determined.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of hubq0797 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the physician flushed the hickman catheter at the end of the procedure and noticed it to be leaking.The catheter was removed and a new one was placed.There was no harm to the patient reported.

• Brand Name: HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: 7054228
• Report Number: 3006260740-2017-02124
• Device Sequence Number: 11298894
• Product Code: LJS
• UDI-Device Identifier: 00801741051852
• UDI-Public: (01)00801741051852
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: N/A
• Device Catalogue Number: 0600564
• Device Lot Number: HUBQ0797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1