MAUDE Adverse Event Report: COVIDIEN PREVENT NEEDLE ONLY 25 X 5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	26558-
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 they had issue with the medication leaking from the syringe where the needle is attached to the syringe.Additional information received from the customer stated that there were no visible connection issues.The customer tested the needle to check if it was a connection issue, she attached a saline flush syringe onto one of the same needle from the same lot number, as she was flushing the saline through the needle it was noted to slowly leak out of the connection site.The needle screwed on to the syringe without difficulty and it was ensured that the needle was screwed on to the syringe completely.The customer further stated that while administering a medication to the patient, leaking was noticed at the needle-connection site.It was a b-12 injection(bright pink in color), so it was easy to see that the medication was leaking.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were ten unopened samples returned for evaluation.The actual samples for this complaint were not sent back for evaluation as they were reported as being discarded.The ten returned samples were visually inspected and leak tested.No visual issues or any leaking hubs were found.A root cause analysis was completed but was unable to identify any issues with the manufacturing process that would have caused the reported condition.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, the samples are inspected for leakage.The reported lot met the acceptance criteria and was released.Based on the available information, there is no indication of a systemic issue with the product or process therefore a corrective action will not be issued at this time.This complaint will be utilized for tracking and trending purposes.

• Brand Name: PREVENT NEEDLE ONLY 25 X 5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11311324
• Report Number: 1017768-2021-00905
• Device Sequence Number: 11713278
• Product Code: FMI
• UDI-Device Identifier: 10612479201351
• UDI-Public: 10612479201351
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 26558-
• Device Catalogue Number: 26558-
• Device Lot Number: 027220
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/02/2021
• Patient Sequence Number: 1