MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM [LONG TERM DUAL-LUMEN]; BLOOD ACCESS AND ACCESSORIES

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2016
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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 stuck introducer needle is confirmed and was determined to be use related.One j-tip guidewire and one 18 g introducer needle were returned for evaluation.An initial visual observation showed the guidewire was bent about 2 inches from the distal j-tip.The weld tip of the guidewire was intact.It was observed during tactile evaluation that the core wire of the guidewire was broken.A microscopic observation revealed use residue at the needle bevel.After the guidewire was removed from the needle, a relatively large amount of biological material was observed on the section of the guidewire that was within the needle.The edges of the needle bevel were observed to be damaged.The fracture site of the corewire was observed to be tapered and appeared to have a granular surface texture, which is evidence of a tensile break.The damage observed on the needle bevel is evidence that the guidewire was retracted against it, which is contradictory to the instruction provided in the ifu.This retraction of the guidewire against the needle bevel is what most-likely caused the blood and tissue residue to become lodged between the guidewire and needle cannula, which, consequently, caused the guidewire to become stuck in the needle.The product ifu states: ¿do not pull back 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 rezf0530 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the introducer needle could not be pulled out for removing after the insertion of guide wire following the accessing to the vein by the puncture needle.On 6/15/2017 - returned wire is frayed.

• Brand Name: VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM [LONG TERM DUAL-LUMEN]
• 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: 6692568
• Report Number: 3006260740-2017-00999
• Device Sequence Number: 11032384
• Product Code: LFJ
• UDI-Device Identifier: 00801741012396
• UDI-Public: (01)00801741012396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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: 05/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 5533190
• Device Lot Number: REZF0530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1