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

Catalog Number	0600662
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 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 photos were visually examined.The first photo shows the proximal end of an introducer needle with a damaged guidewire protruding from the pink hub.The guide wire straightener is also visible on the guidewire.The guidewire is unraveled significantly, with the damaged core wires visibly protruding.The second photo shows the tyvek lid stock with product label.The photographic evidence suggests the guidewire may have sustained needle damage during use, but the photographic evidence is not substantial enough to determine cause.The ifu states, ¿gently withdraw and remove needle.Caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of rezc2397 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - facility reported during insertion of the device, allegedly the wire came apart.The procedure was stopped, a new device was opened to complete the procedure.
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 complaint of a damaged guidewire 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 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.Reference (b)(4) for further information regarding this failure mode.The ifu states ¿gently withdraw and remove needle.Caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.¿.

• 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: 5931269
• Report Number: 3006260740-2016-00474
• Device Sequence Number: 16291172
• Product Code: LJS
• UDI-Device Identifier: 00801741037511
• UDI-Public: (01)00801741037511(17)200328(10)REZC2397
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2016

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: 03/28/2020
• Device Catalogue Number: 0600662
• Device Lot Number: REZC2397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2016
• Supplement Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1