MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON SYRINGES WITH SAFETY HYPODERMIC NEEDLES; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Activation Failure (3270)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not returned for evaluation; instead, a photo of the unblistered actual sample was provided by the customer.The defects that can contribute to the complaint cannot be confirmed in the photo.The retention samples were visually inspected and confirmed free from defects that will affect activation of the safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion collar to the hub, sheath-collar fitting, tilted cannula, and damaged parts.The samples were further evaluated for the sheath activation and deactivation functional test wherein all samples passed.A total of sixteen (16) complaints were received from the previous two (2) fiscal years to the present for the same issue where most of the problems are related to usage particularly due to improper activation of the device (not activating with a one-handed technique using the three methods: finger, thumb, and hard surface).Based on the investigation of individual complaints there was no attributable cause noted related to our product and production process.The root cause of the complaint could not be identified to be related to our production or process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot and the retention samples met the required specifications.Simulation through manual sheath activation was conducted on the retention samples.An audible click was heard indicating successful safety activation.The needle is fully engaged under the lock (sheath tooth) and no irregularity during and after activation was encountered that may lead to the complaint.Series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to ensure that no defects will be encountered that will lead to sheath activation problems and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.We advise you to follow the instructions for use (ifu) indicated in the unit box for the proper usage of sg3 safety needles in which warnings to prevent needlestick, cautions, and precautions are also included.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 involved mckesson syringes with safety hypodermic needles was used to administer a sq heparin shot to a patient when a nurse incurred a needle stick.The needle stick occurred due to the difficulty in putting the safety lock on the needle.Additional information was received on 29 aug 2023: the patients health was not impacted in any way.The patient's injection was received as intended.The staff member was not activating the needle against a hard surface when the needle stick occurred.It was incurred in the index finger of the staff member during a patient's medication administration in the room.The needle was exposed around the sheath when the needle stick occurs.Per occ med guidance, testing was required after the needle stick to determine bloodborne pathogen (bbp) exposure.The needle stick did not cause blood loss or require additional treatment aside from the first aid.The staff member that incurred the needle stick condition is stable and has returned to work.

• Brand Name: MCKESSON SYRINGES WITH SAFETY HYPODERMIC NEEDLES
• 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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17762176
• MDR Text Key: 323632430
• Report Number: 3003902955-2023-00043
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 20612479246625
• UDI-Public: 20612479246625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2023
• 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-SNT1C2705S3
• Device Lot Number: 221221D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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
• Treatment: SQ HEPARIN