MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER BASIC TRAY (5F) (DUAL-LUMEN) (MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 8275118

Device Problems Break (1069); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2018

Event Type  malfunction  

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, 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 damaged guidewire was confirmed and the cause appeared to be use related.The product returned for evaluation was a set of photographs showing a break in both the coil wire and core wire.The physical sample was subsequently returned.The core wire broke 2.1cm from the weld tip.The distal segment of the guidewire was received in the needle.The outside diameter of the guidewire was measured near the weld tip and was found to be within specification.The coil wire had kinked at the needle bevel.After removing the wire from the needle, a microscopic examination revealed deformation in the needle bevel.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.Reference (b)(4) for further information regarding this failure mode.One of the precautions in the ifu states, ¿if the guidewire must be withdrawn while needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of rebs0001 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during the installation of the picc catheter, after the puncture, it was made the introduction of the entire path and at the time of sliding, it feels that it attaches in the walls of the needle with difficulty to pass.So it was decided to remove the guide (with much resistance).The needle was slid along with the guide and the detachment of the soft part of the guide is observed and it get attached to the needle.Another device is installed with no adverse event that could damage the patient's health.Update 04/30/2018 - the returned guidewire is unraveled and has a break in the tip.

• Brand Name: POWERPICC CATHETER BASIC TRAY (5F) (DUAL-LUMEN) (MICROINTRODUCER)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7535511
• MDR Text Key: 109007246
• Report Number: 3006260740-2018-01040
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139901
• UDI-Public: (01)00801741139901
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 8275118
• Device Lot Number: REBS0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1