MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT XK LONG-TERM HEMODIALYSIS CATHETER 16F STANDARD KIT; BLOOD ACCESS AND ACCESSORIES

Catalog Number	5683730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2016
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 following were reviewed as part of this investigation: patient severity, trend 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 guidewire complications was confirmed and the cause appears to be use related.The product returned for evaluation was one 18ga introducer needle and one j-tip guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the guidewire was broken and the coil wire was unraveled.The damage region extended from at the distal weld tip.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination of the fracture sites revealed the following: material necking of the wire at the break which is a characteristic feature of a strong pull on the wire.Damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel.Biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.The product ifu provides the following warning: ¿caution: do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of reaq1326 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the nurse was unable to advance the guidewire.Another kit was opened and used successfully, no patient harm.

• Brand Name: HEMOSPLIT XK LONG-TERM HEMODIALYSIS CATHETER 16F STANDARD KIT
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5919150
• Report Number: 3006260740-2016-00470
• Device Sequence Number: 521700
• Product Code: MSD
• UDI-Device Identifier: 00801741012730
• UDI-Public: (01)00801741012730(17)180228(10)REAQ1326
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

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: 02/28/2018
• Device Catalogue Number: 5683730
• Device Lot Number: REAQ1326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1