MAUDE Adverse Event Report: COVIDIEN 16G X 1 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2019
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 reported that when drawing up medication, the needles break off right at the hub.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for cannula to hub pull outs or damaged components.The lot met the acceptance criteria and was released.Seventy-four unused samples were received at the manufacturing site for evaluation.An empty cartridge with a witness mark was also included in the opened box.All samples were visually inspected for damage in the cannula and no issues were found.All needles had a visible and well-defined window and nose of the hub.30 samples out of the 74 were randomly selected for cannula pull test and all 30 samples passed inspection.The reported condition could not be confirmed.A root cause could not be determined as the reported issue was not confirmed.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the product or process.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 16G X 1 A (ALUM HUB) RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9530064
• Report Number: 1017768-2019-00768
• Device Sequence Number: 2341328
• Product Code: FMI
• UDI-Device Identifier: 30884521007592
• UDI-Public: 30884521007592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: No Information
• Device Model Number: 8881200052
• Device Catalogue Number: 8881200052
• Device Lot Number: 906325
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1