MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HOHN PERCUTANEOUS 7F DUAL-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 information provided by bd 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 bd.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redr0516 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redr0516) have been reported from the same facility.- (b)(4).
Event or Problem Description
It was reported via medwatch, "a hole was noted in the hohn catheter.The patient was sent to ir for an exchanger.".
Additional Manufacturer Narrative
The information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole in a catheter is confirmed and was determined to be use related.One 7 fr dual lumen hohn catheter was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.A large, mostly circumferential split was observed in the extension leg of the white lumen approximately 1.5 cm distal to the strain relief of the luer hub.Tensile weakness was observed in the extension leg at multiple locations between about 0.8 cm and 3.5 cm distal to the split.A microscopic observation revealed the split curved around nearly the entire circumference of the extension leg tubing with one side of the split converging into a ¿v¿-shape with a curved longitudinal split at its point.The fracture surfaces were observed to be smooth and granular in texture and angled and slightly rough at one location near the ¿v¿-shaped portion of the split.Additional longitudinal, superficial splitting/tearing could be seen on the inner wall of that catheter opposite the ¿v¿-shaped portion of the split.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The product ifu states: ¿do not force fluids as catheter damage may result.¿ and ¿do not use a syringe smaller than 10 ml!¿ the product ifu also contains recommendations on clearing blocked catheters.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of redr0516 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redr0516) have been reported from the same facility.(b)(4).
Event or Problem Description
It was reported via medwatch, "a hole was noted in the hohn catheter.The patient was sent to ir for an exchanger.".

• Brand Name: HOHN PERCUTANEOUS 7F DUAL-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: 9224651
• Report Number: 3006260740-2019-03286
• Device Sequence Number: 13880931
• 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): 10/30/2019

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: 0600730
• Device Lot Number: REDR0516
• 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: 10/23/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR