MAUDE Adverse Event Report: DELTA HI-TECH, INC. AIMSCO; PEN NEEDLE

Catalog Number 622

Device Problems Product Quality Problem (1506); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

End user reports the pen needles were bending when he was inserting the pen needle into his stomach skin.

Manufacturer Narrative

Initial trend analysis for lot 50133 was conducted, no malfunctions were found.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports the pen needles were bending when he was inserting the pen needle into his stomach skin.

Manufacturer Narrative

No device was returned for testing.Production records were inspected and testing shows no indication of abnormalities or malfunction at time of production.

Manufacturer Narrative

No device was returned for testing.Production records were inspected and testing shows no indication of abnormalities or malfunction at time of production.

Event Description

End user reported on (b)(6) 2022 the pen needles from lot 50133 were bending when he was inserting the pen needle into his stomach skin.End user reported again on (b)(6) 2022 that pen needles from lot number 50133 are still bending when injecting and the end user does rotate the injection sites.

• Brand Name: AIMSCO
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): DELTA HI-TECH, INC.; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): DELTA HI-TECH, INC.; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 14251781
• MDR Text Key: 299455469
• Report Number: 3001123929-2022-03056
• Device Sequence Number: 1
• Product Code: FMI
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2024
• Device Catalogue Number: 622
• Device Lot Number: 50133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2022
• 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