MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRINGE, 10ML SALINE IN 10ML

Catalog Number EMZE010001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was diagnosed with an unidentified infection after use of the saline syringe.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient or product information related to the reported incident.It is unknown how long after use of the saline syringe that the patient was diagnosed with the unidentified infection.It is unknown how the saline syringe was originally used.No information related to diagnostic exams or results, medical intervention, or follow-up care was disclosed to the manufacturer.No sample was returned to the manufacturer for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the patient was diagnosed with an unidentified infection after use of the saline syringe.

Manufacturer Narrative

Communication was received from the facility contact requesting the manufacturer to discontinue further investigation into the originally reported incident.No information was provided indicating that the use of the saline syringe caused or contributed to the reported patient infection.The original medwatch was filed in an abundance of caution due to the initial reported concern.In the absence of a returned sample, a device history record review was conducted for the specified lot.The lot met all specifications and there were no non-conformances.If additional relevant information becomes available, another supplemental medwatch will be filed.

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7864560
• MDR Text Key: 119875261
• Report Number: 2027791-2018-00001
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30888277675814
• UDI-Public: 30888277675814
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMZE010001
• Device Lot Number: 3132594
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other