MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR. DUAL LUMEN CATHETER 36CM OVERALL LENGTH; BLOOD ACCESS DEVICE & ACCESSORIES

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reaz1308 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the patient had catheter placed for a duration of 3 days for treatment.After completing treatment, it was noted that the catheter was broken at the cuff.Patient had surgery to remove the broken piece.No harm to the patient.
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 catheter break is confirmed; however the cause is unknown.One 13.5 fr dual lumen hickman dialysis catheter was returned for evaluation.An initial visual observation showed blood residue throughout the sample.The catheter was observed to be broken just proximal to the cuff.Suturing material was observed approximately one inch distal to the bifurcation.Some tensile weakness was observed in the extension tubing of the red line.A microscopic observation revealed both fracture sites were uneven with mostly granular surface textures; however some jagged-edged slits and indentations were also observed on the fracture surfaces.An edge of the fracture site on the distal segment was observed to be slightly rounded.Multiple superficial circumferential splits were observed on the outer surface of the catheter near the edges of both fracture sites and appeared to be mostly straight, smooth, and glossy.The cause of the break in the returned sample is unknown; however, possible causes include sharp instrument damage and material fatigue.
Event or Problem Description
It was reported by the facility that the patient had catheter placed for a duration of 3 days for treatment.After completing treatment, it was noted that the catheter was broken at the cuff.Patient had surgery to remove the broken piece.No harm to the patient.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR. DUAL LUMEN CATHETER 36CM OVERALL LENGTH
• Common Device Name: BLOOD ACCESS DEVICE & ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6644545
• Report Number: 3006260740-2017-00785
• Device Sequence Number: 13835534
• Product Code: LJS
• UDI-Device Identifier: 00801741037511
• UDI-Public: (01)00801741037511(17)211231(10)REAZ1308
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 0600662
• Device Lot Number: REAZ1308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1