MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - supplier quality specialist.Based from the results of our investigation, the root cause of the complaint could not be identified as of this time.Reference photo of actual samples showed 3pcs of blister top film wherein print seems to be scratched and erased but hole could not be confirmed through the photo.However, actual condition of samples to verify the potential source could not be confirmed since sample is not yet available for our evaluation.Checking of our records for the provided carton boxes no.Inspected by the customer showed no similar defect noted related to blister package.We have checked our inspection records (top film and sg blister packaging), machine layout of top web printing and sg blister packaging as well as inspectors involved during our production.However, no possible source of the defect was found.Confirmation showed no similar defect of damage to package was noted on a total of (b)(4) pieces products from b-line.Further investigation will be conducted upon arrival of actual sample to verify the potential sources based on the appearance and condition of actual sample.This report will be updated accordingly.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.(b)(4).
Event or Problem Description
The user facility reported that they had needle blisters with damage and holes impacting sterility.This was observed during packaging.This is a processable defect with potential impact on the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device returned date in the d10 section, to update the h3 section and to provide the completed investigation results.H6: result codes- 4210 leakage / seal is based off the samples, 213 no failure detected is based off the retention samples.Six actual samples were received and was observed with scratches and dents with print that seemed to be erased.The hole was confirmed on top of the film of sample 3 and 5.The location of dents, scratches and hole on package were confirmed not parallel to the molded parts edges which means that this portion will not likely to generate hole on package.Process confirmation showed no sharp edges or any protruded parts on the blister packaging as well as on the top web printing and udi printing station that could lead to hole on packaging during the process.Different simulation was conducted related to handling wherein results showed no similar conditions to the complaint sample was created.Furthermore, ncr masterfile and raw material nonconformity masterfile from fy2018 to fy2019 showed no issued ncr related to hole on package.

• Brand Name: TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 9853266
• Report Number: 3003902955-2020-00015
• Device Sequence Number: 14119291
• Product Code: MEG
• UDI-Device Identifier: 34806017507085
• UDI-Public: 34806017507085
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SG2+2238
• Device Lot Number: 181105B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1