MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO HYPODERMIC NEEDLE

Model Number	AH+2516-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle broke off in patient during use.Needle also broke again when being surgically removed.No additional information was provided.((b)(6) year old female spayed, aussie shepherd mix, (b)(6) pounds).
Additional Manufacturer Narrative
Investigation report attached is on unused retained samples from same lot.
Event or Problem Description
Needle broke off in patient during use.Needle also broke again when being surgically removed.No additional information was provided.((b)(6) female spayed, aussie shepherd mix, (b)(6)).

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 9782282
• Report Number: 8041145-2020-00002
• Device Sequence Number: 687918
• Product Code: FMI
• UDI-Device Identifier: 00383790002066
• UDI-Public: 00383790002066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: AH+2516-1M
• Device Catalogue Number: AH+2516-1M
• Device Lot Number: 18E07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 28