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

Model Number N/A

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: program manager, compliance and environmental health & safety.The actual device was not returned to the manufacturing facility for evaluation.Based from the results of our investigation, the root cause of the complaint could not be identified.The condition of the actual sample was not confirmed since it was not returned for evaluation.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath activation and deactivation were all passed.In addition, the safety sheath was successfully activated without any difficulty during simulation similar to the complaint.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, sensory, and functional inspection to assure lots are in good quality.All samples passed.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (b)(4) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that while closing, the cover went to the side instead of straight down.Resulted in a needle stick.The employee gave a flu shot to a patient.After giving the flu shot, when the employee activated the safety device, the safety cover went on the side instead of going straight, resulting in a needlestick injury on her left thumb.The employee's condition is unknown.The injection performed as intended.Needle stick incurred post injection.Additional information was received 22january2020: there was no difficulty with the needle, during the delivery of stated flu shot.No bent needle was noted.The thumb was used to engage the safety.There was no impact for the patient who received the flu shot.The flu vaccine was attached to needle within a pre-filled vial, or syringe.The subject needle was attached, just prior to patient injection.The employee was required to go for diagnostic testing for bbp exposure completed per facility protocol.The employee since has returned to their role at the facility, with no further health impact.Device was disposed.

• 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
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: theresa mussaw ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9636558
• MDR Text Key: 221016122
• Report Number: 3003902955-2020-00003
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 190903B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 59