MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRSI101292-SYR W/NDLE, SAFETY, INSLN, 1ML, 29GX0.5"

Catalog Number SYRSI101292

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/17/2019

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that after the nurse administered insulin to a patient the nurse experienced a needle stick.Per the facility report, after injecting the insulin with her right hand the nurse attempted to use her right index finger to push the safety slide up to activate the feature and she punctured her right index finger with the used syringe.The nurse washed the area with soap and water and went to the local hospital to have a hepatitis panel and hiv test performed per facility protocol.Per the facility report the nurse is feeling fine and there is no evidence of infection.The actual needle used was disposed of and was not returned to the manufacturer for evaluation, according to the reported incident the root cause was determined to be user error.No additional information is available.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 by the facility that after the nurse administered insulin to a patient the nurse experienced a needle stick.

• Type of Device: SYRSI101292-SYR W/NDLE, SAFETY, INSLN, 1ML, 29GX0.5"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9413277
• MDR Text Key: 169218608
• Report Number: 1417592-2019-00220
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SYRSI101292
• Device Lot Number: 89719060002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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