MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx1327 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recx1327) have been reported from the same facility in (b)(4).

Event Description

It was reported that after the puncture and the rise of the guide, we found an impossibility to remove the guide, it is stuck to 1.5 cm under the skin.Call of an anesthetist doctor, who managed to withdraw it by forcing.It was stated this has happened twice.This report addresses the second event.

Event Description

It was reported that after the puncture and the rise of the guide, we found an impossibility to remove the guide, it is stuck to 1.5 cm under the skin.Call of an anesthetist doctor, who managed to withdraw it by forcing.It was stated this has happened twice.This report addresses the second event.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the exact cause is unknown.One 0.018 in.Nitinol guidewire, one 21 g introducer needle, and one 4 fr sl power midline with a stylet inserted were returned for evaluation.An initial visual observation showed use residue throughout the returned samples.The distal end of the guidewire was observed to be slightly bent.The core wire of the guidewire was observed to be intact during tactile evaluation.A microscopic observation revealed no damage on the needle bevel.Some delamination was observed in the adhesive at the proximal junction between the core wire and the coiled wire.A gap was observed between the weld tip and the coiled wire.A large amount of blood residue was observed on the coiled wire of the guidewire.While the exact cause of the damage in the guidewire is unknown, possible contributing factors include guidewire caught in patient tissue, forceful insertion/retraction of the guidewire against resistance, and rapid removal of the guidewire.The product ifu cautions: ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8597239
• MDR Text Key: 144708629
• Report Number: 3006260740-2019-01329
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141034
• UDI-Public: (01)00801741141034
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P6154118
• Device Lot Number: RECX1327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1