MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the staff said that the needle was difficult to use and noticed rust on the needle.It was reported that it was not a penetration issue.The staff stated it was difficult to inject the fluids through, almost as if it was clogged.Looking closely at the needle, they noticed discoloration, that appeared to be rust.One was opened and a staff finger ran over it and the discoloration transferred to the finger.They were concerned that chunks of the rust were clogging the needles.They checked the stock in both buildings, and this box lot and two pieces were the only ones they identified with the issues.Difficult fluid delivery and rust.They stopped using this lot and have not had the issue since.No animals were harmed due to issue.Additional information was received on 07december 2021: the tech had just opened the device, when discoloration was noted.The needle was not used during any animal procedure.They could not confirm exact receipt date of product, or storage time but stated it could not have been in facility for more than 2 months prior to the issue.Also, the needles are distributed by techs who move the new product from locked medical storage and distribute into surgical suites as supply demands.They try to keep 3 boxes (100 pc) of 18 g in the suites at a time.The rust samples would not have been exposed to any cleaning solutions or chemicals.It was stated even if a sleeve of packaged needles drops in a wet area during procedure, they immediately dispose of the sleeve.Additional information was received on 09december 2021: storage conditions in (b)(6) provided as follows: normal storage temperatures are around 70 f at (b)(6).(b)(6) is heated and air conditioned and typically is between 65 f and 75 f throughout the year.No chemicals or anything are used on the cartons in (b)(6).
Additional Manufacturer Narrative
Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Operator of device: staff.Implanted date: no patient involvement.Explanted date: no patient involvement.Initial reporter occupation -manager / vet tech.The root cause of the complaint could not be identified at this time.The received actual sample was confirmed to have rust on the cannula body.Based on our checking, the defect could not have originated on our process, thus, this issue was communicated with the supplier.Based on our records the involved needle lot 200818fn has undergone product confirmation for black fm on cannula due to the replacement of the cannula rubber hold at the bonding station.No defect was noted (0/15,116 pieces) and these are confirmed not related to any rust like foreign matter.Retention samples of the affected lots supplied with the involved cannula were visually inspected wherein no similar defects or any anomalies that could lead to the complaint were observed.Also, the monitoring record of the temperature and humidity showed no abnormalities during the staging of the affected products that could lead to the formation of rust on the product.We have weekly machine maintenance cleaning to ensure that our needle assembly machines are consistently in good running condition and free from damage and contaminants.Moreover, in-process visual inspection is conducted during needle assembly and qc conducts outgoing visual inspection prior to shipment to confirm the condition of our products.The investigation for this nonconformity is still ongoing.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.This final investigation is based on the available information both from the production process and supplier raw material process.One of the received samples showed 1-piece unblistered sample with lot number 200925c.A rust-like foreign matter on the cannula body was observed.The root cause of the complaint could not be confirmed as related to our manufacturing process as well as the supplier's process.As per tc, there was no assignable cause observed during their cannula process since the cannula production records specifically in the grinding and washing process were confirmed with no abnormalities observed and no similar defect was found in their sampling inspection.Based on tc's evaluation results from previous simulation, the level of defect found in this complaint lots can be removed from their washing process.Checking of records and machine conditions at needle assembly were also done, the contact of work hold on the cannula body has a distance ranging from 4mm to 12mm wherein the contact could not lead to rust similar to the actual sample.

• Brand Name: TERUMO NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13014314
• Report Number: 3003902955-2021-00071
• Device Sequence Number: 1816625
• Product Code: FMI
• UDI-Device Identifier: 34806017511839
• UDI-Public: 34806017511839
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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
• Device Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: NN1825R
• Device Lot Number: 200925C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown