MAUDE Adverse Event Report: ULTIMED, INC PUBLIX; 0.3CC, 31G X 5/16" U100 INSULIN SYRINGE

Catalog Number 192163

Device Problem Device Issue (2379)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

Summary: customer stated had a needle stick from one of our bags of publix insulin syringes.The cap came off and the needle was exposed, lot # a50214, item 192163 (b)(4).A total of (b)(4) inner boxes was received in april 2015.The (b)(4) inner box units were shipped out to various customers.No product was returned with complaint.Review of incoming inspection records indicated no issues with this lot.No other complaints on this lot.Device not returned.

Event Description

Customer stated had a needle stick from one of our bags of insulin syringes.Cap came off and needle was exposed.Lot # a50214, item # (b)(4).

• Brand Name: PUBLIX
• Type of Device: 0.3CC, 31G X 5/16" U100 INSULIN SYRINGE
• Manufacturer (Section D): ULTIMED, INC; 710 fourth street se; po box 476; de smet SD 57231
• Manufacturer (Section G): ULTIMED, INC; 710 fourth street se; po box 476; de smet SD 57231
• Manufacturer Contact: jeff heaton ; 350 highway 7; ste # 100; excelsior, MN 55331 ; 6512917909
• MDR Report Key: 5701826
• MDR Text Key: 47896558
• Report Number: 2135402-2015-00012
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 192163
• Device Lot Number: A50214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2015
• 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