MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HOHN PERCUTANEOUS 5F SINGLE-LUMEN CATHETER BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recz2002 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch, "attempted to flush patient's red lumen of right internal jugular hohn catheter and the line perforated.The clamp was moved closer to the patient and the lumen was de-accessed and replaced in interventional radiology.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.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 7fr d/l hohn acute central venous catheter.Usage residues were observed throughout the sample.An adhesive dressing was wrapped around the red-luered extension tube.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, when flushing the red-luered lumen, a leak was observed near the over-sleeve.Tactile inspection of the sample revealed tensile weakness and necking throughout both extension tubes.Multiple clamping impressions were observed, and the leak occurred within one of those impressions.Microscopic inspection of the leak site revealed a small split.The split exhibited a granular fracture surface.The split edges curved inward slightly.Material wear was observed in the vicinity of the split.The leak appeared consistent with damage accumulated through repetitive clamping within the same region.A lot history review (lhr) of recz2002 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch, "attempted to flush patient's red lumen of right internal jugular hohn catheter and the line perforated.The clamp was moved closer to the patient and the lumen was de-accessed and replaced in interventional radiology.".

• Brand Name: HOHN PERCUTANEOUS 5F SINGLE-LUMEN CATHETER BASIC KIT
• 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: 9224652
• Report Number: 3006260740-2019-03285
• Device Sequence Number: 150544
• Product Code: LJS
• UDI-Device Identifier: 00801741036361
• UDI-Public: (01)00801741036361
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 0600710
• Device Lot Number: RECZ2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR