MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. MVP; INSULIN SYRINGE

Catalog Number 819550

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

We have been using your mvp u40 29gauge.5mlcc 1/2" vet syringes to administer insulin to our diabetic cat for 7 years.Every once in a while the box of 100 syringes would be missing a needle or needle would be bent and unusable.A recent box of 100 needles so far has had one missing needle, a bent needle and last evening the needle was inserted to side where if used the insulin would have just come back out of syringe.We still have more than 30 needles left in this box but now have to check each one of them thoroughly since the quality appears to have gone done.Very disappointed.Just wanted to bring this to your attention.(if you need to reach us we prefer email.Thank you).Called (b)(6) to get additional information, she purchases 3-4 boxes at a time.She has issues every now and then, but in this box she had 3 syringes that were bad.One of the needles fell out of the syringe.One of the needles were bent and the syringe will have a needle not placed into the syringe correctly, it would be inserted to the side.If she were to insert it into the insulin bottle and tried to inject her cat, it would get on her cat's fur.I requested pictures to be emailed, she only has 1 syringe to show due to throwing the other 2 away.

• Brand Name: MVP
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7825413
• MDR Text Key: 118528935
• Report Number: 3005798905-2018-00846
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 819550
• Device Lot Number: 44066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2018
• 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