MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; PICC STD KIT 4F SL PL

Model Number	DYNJ70141
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional 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.Tehrani payam, 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: on 7/28/2021 08:32:33 cst (bgomes).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 or Problem 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.
• Common Device Name: PICC STD KIT 4F SL PL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12246504
• Report Number: 1038445-2021-00006
• Device Sequence Number: 17095531
• Product Code: LRO
• UDI-Device Identifier: 10889942565047
• UDI-Public: 10889942565047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention