MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problems Difficult or Delayed Activation (2577); Activation Problem (4042)

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: bsn, rn.The actual device has not been returned to the manufacturing facility for evaluation.Based from the results of our investigation, the root cause of the complaint could not be identified.Reference photos of actual sample showed 1-piece unopened blister sg2 needle.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath activation, sheath deactivation and sheath radial strength were all passed.In addition, the safety sheath was successfully activated without any difficulty during simulation and no protruding or bending of cannula was noted.We have series of visual in-process inspection to detect abnormality on the sheath that may lead to problem during sheath activation.Molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problem.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior shipment, qc conducts outgoing visual and sensory inspection to assure lots are in good quality.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

Event Description

The user facility reported that the safety on the mckesson medi-pak performance safety hypodermic needle takes a great deal of pressure to lock completely.The safety would flip up after use and will appear to be engaged when in reality it is not and it can flip back down leading to a needlestick risk (there was one needlestick due to this).Additional information was received 21january2020: the nurse had blood work done and will have a follow up screening in 6 months.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the unused sample return date in the d10 section, to update the h3 section and to provide the completed investigation results.Retention and received same lot samples were confirmed free from defects that will affect activation of safety sheath.Moreover, both samples were subjected to related functional testing such as sheath activation, sheath deactivation and sheath radial strength were all samples passed.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 9632703
• MDR Text Key: 219573961
• Report Number: 3003902955-2020-00002
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (y/n): N
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 190727B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1