MAUDE Adverse Event Report: COVIDIEN SHIONOGI 25 X 5/8 R PKG; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	5551390558
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports 61 split needle hubs were identified.
Additional Manufacturer Narrative
The device history record (dhr) for the lot indicates no defects were found in visual samples inspected from the lot.There were two samples returned for evaluation for this complaint.The samples were visually inspected.One sample appeared to have the side of the hub scratched through and the second hub appeared to be split.The reported condition is confirmed.The complaint file contains insufficient evidence to determine a most probable root cause of the split hub.The most likely root cause of the scratched hub is the hub loader.Awareness training for damaged hubs was completed and a new assembly machine is being installed and validated.This information will be utilized for trending purposes to determine the need for additional corrective actions.

• Brand Name: SHIONOGI 25 X 5/8 R PKG
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8704067
• Report Number: 1017768-2019-00651
• Device Sequence Number: 1992296
• Product Code: FMI
• UDI-Device Identifier: 10884521184244
• UDI-Public: 10884521184244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: No Information
• Device Model Number: 5551390558
• Device Catalogue Number: 5551390558
• Device Lot Number: 831648
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1