MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH); NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
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: na, implanted date: device was not implanted, explanted date: device was not explanted, health professional: unknown, occupation: supplier quality specialist.Based on the available information and the results of our investigation, the complaint is possibly a slip through during the 100% visual inspection for damage to the package.Performance testing of shipping containers was conducted during validation of the blister packaging to evaluate the integrity of the packaged products as the product goes through shocks and stresses normally encountered during handling and transportation.The verification of the package performance was conducted last august 20, 2021 through an engineering test report.The product has undergone simulated shocks and stresses which are normally encountered during handling and transportation of products until it reaches the end-user.Based on the results of the shipping and handling test no damages or holes were found on the blister packaging and the design of packaging for sg3+2713 can provide adequate protection on the contents during normal handling and transit.The lot has undergone 100% inspection wherein 2-pieces of product with damage to the package were found.The following corrective action was implemented to address the slip thru on the inspection.Refreshers training on the inspection procedure ((b)(4): finished product inspection treatment procedure and (b)(4): sg finished product inspection work instruction) was conducted last august 23, 2021, to reiterate the method of inspection.Revision of the document to make emphasis on the step-by-step procedure for damage to package inspection.Additional 1-time eye rest was implemented last august 26, 2021, to prevent eye strain.This complaint is still for further investigation.Therefore, a follow up report will be submitted once the investigation is complete.(b)(4).
Event or Problem Description
The user facility reported that there was a hole the pouch during production of fd9264.There was no 100% mvi check.A sample set of 800 pieces has been found with no additional defects.The hole on the blister affecting sterility was not visible to the user, hence, probability of using the unsterile product is high.There was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to report that this reported event has been reassessed and deemed not a reportable complaint based upon an internal review.This reported issue has been confirmed to have already been covered under an existing damage to package investigation.The lot was not shipped to the customer but was discovered and trapped during the 100% product inspection, which is one of our corrections for this issue.For the damage to package investigation, please see mdr 3003902955-2021-00044.

• Brand Name: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH)
• 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: 12639179
• Report Number: 3003902955-2021-00052
• Device Sequence Number: 11892810
• Product Code: FMI
• UDI-Device Identifier: 34806017509713
• UDI-Public: 34806017509713
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K122249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: SG3+2713
• Device Lot Number: 210313D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2021
• 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