MAUDE Adverse Event Report: DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reey1076 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported stylet frayed when attempting to remove.No other information was provided.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.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 broken stylet is confirmed.One 4 fr single lumen powermidline with a stiffening stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The stiffening stylet was observed to be broken and unraveled.The pinch clamp was observed to be engaged and the distal end of the stylet was found to be positioned underneath the closed clamp within the extension leg.The coiled wire of the stylet was found to unravel beginning about 2.4 cm proximal to the pinch clamp.After dissection of the catheter, the distal end of the stylet was found to be positioned near the 2 cm depth marker, and the distal weld tip of the stylet was found to be missing.A microscopic observation revealed the break sites of both the core wire and the coiled wire were angled and slightly curved with some deformation at the most proximal side of the break.The break surfaces of the core wire and coiled wire were observed to be flat and somewhat granular in texture.No unraveling of the coiled wire was observed leading up to the break site.The features of the breaks observed in the returned sample suggest the stylet was sheared off due to a force applied from a hard surface or instrument.The product ifu states: ¿the stylet or stiffening wire needs to be well behind the point the catheter is to be cut.Never cut the stylet or stiffening wire,¿ ¿never use force to remove the stylet,¿ and ¿do not clamp extension leg when stylet or stiffening wire is in catheter to minimize the risk of component or catheter damage.¿.

Event Description

It was reported "stylet frayed when attempting to remove.".

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: MIDLINE CATHETER
• MDR Report Key: 12093680
• MDR Text Key: 259207558
• Report Number: 3006260740-2021-02486
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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: P4154108D
• Device Lot Number: REEY1076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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
• Patient Outcome(s): Other