MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DYNJ70141

Model Number DYNJ70141

Device Problems Dull, Blunt (2407); Failure to Advance (2524)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "needles are not sharp enough, and the guidewires could not be inserted." physician reports multiple attempts to insert picc line all with failed attempts.Email received by dr.(b)(6), chief medical office, who provided additional information.Physician (reporter) states, "within the last 2-weeks, we tried 5-kits (standard picc kit), each on 5 different patients.None were successful." reporter was unable or unwilling to provide specific dates and times or patient identification information.Four additional complaints have been open to reflect additional reported incidents.Reporter states, all attempts were to the "basilica vein, withdrew after failed attempts." sample has been returned, evaluation/investigation summary below.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Investigation summary: 7/28/2021 08:32:33 cst (b)(6).The account reported finding the needles are not sharp enough for the guidewire to be inserted.The reported issue occurred in item dynj70141 (lot 21cdb158).Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process.

Event Description

It was reported, "needles are not sharp enough, the guidewires could not be inserted." physician reports multiple attempts to insert picc line all with failed attempts.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: DYNJ70141
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 12247132
• MDR Text Key: 266163470
• Report Number: 1038445-2021-00010
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942565047
• UDI-Public: 10889942565047
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ70141
• Device Catalogue Number: DYNJ70141
• Device Lot Number: 21CDB158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention