MAUDE Adverse Event Report: COVIDIEN PREVENT NEEDLE ONLY 25 X 1; NEEDLE, DENTAL

Model Number	26559
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
Customer reports: the needles have plastic particles inside the needle sheath as well as on the needles.
Additional Manufacturer Narrative
Correction: d3 manufacturer name corrected.Evaluation summary: the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected.A review of the entire dhr showed no manufacturing or inspection anomalies.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.There were 3 samples and 4 photos returned for evaluation.The reported condition could not be confirmed from photos or samples.No plastic particles were seen inside the needle sheath or on the needles.The exact root cause could not be determined based on available information.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 fluid path needle contamination.The lot met the acceptance criteria and was released.There is no indication of a systemic issue with the product or process, so a corrective and preventative action (cap)a will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.
Additional Manufacturer Narrative
Section d4 (lot number); initially reported as 003416 and based on clarification from the manufacturing site, the lot number should be 007624.

• Brand Name: PREVENT NEEDLE ONLY 25 X 1
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10453801
• Report Number: 1017768-2020-00841
• Device Sequence Number: 19904564
• Product Code: DZM
• UDI-Device Identifier: 10612479201382
• UDI-Public: 10612479201382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2022

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
• Device Model Number: 26559
• Device Catalogue Number: 26559
• Device Lot Number: 007624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 08/20/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/21/2020; 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown