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

Model Number 8881200052

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2019

Event Type  malfunction  

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 Description

The customer reported that when drawing up medication, the needles break off right at the hub.

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
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9530064
• MDR Text Key: 173085061
• Report Number: 1017768-2019-00768
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30884521007592
• UDI-Public: 30884521007592
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881200052
• Device Catalogue Number: 8881200052
• Device Lot Number: 906325
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1