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	08/09/2021
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.Initial reporter 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 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 lot has undergone 100% inspection wherein 2-pieces of product with damage to the package were found.A follow up report will be submitted once the investigation is complete.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 or Problem Description
The user facility reported that there was a hole in the pouch.One defect was found during production of (b)(4).There was no 100% mvi check.A sample set of 800 pieces has been found.There was no additional defects found.No patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The received actual sample showed 1 piece unopen sg3 blistered needle.Some dents on different location of the printed top web and a hole below the gauge indication was seen on the packaging.A scratch prior the hole was also observed.The location of the hole was compared with the position of the product inside the blister packaging.It was confirmed that the location of the hole on the package was confirmed parallel with the molded parts edges.Based on the results of our investigation, the complaint originated from our visual inspection process.Inspection records revealed that some inspectors were assigned to the visual inspection but not yet fully requalified to perform the task specifically on the requirement of ics which is being performed every 6 months.As a corrective action, training and information were completed last august 25, 2021, regarding the following requirement: manpower allocation requirement; inspection procedure the ph-pqc-qa016 - finished product inspection treatment procedure and ph-pqa032- sg finished product inspection work instruction.The procedure, ph-pqdsg032 will be revised to emphasize the inspection of the damage to package defect which will be completed on october 4, 2021.A total of (b)(4) pieces of sg3 needles were shipped from 2016 to may 2021.This is the first time to receive the damage to package (hole) complaint on sg3 needles.Moreover, to ensure that handling and vibration incurred during transportation do not have an impact on the product, 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.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 instead of follow-up no.3 for a correction to the mfr number on mdr 3013394970-2021-00044.3013394970-2021-00044 follow-up no.2 mdr was submitted june 28, 2022, with the mfr report number inadvertently filled out as 3013394970-2021-00044.The correct mfr number should have been 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: 12380413
• Report Number: 3003902955-2021-00044
• Device Sequence Number: 14586808
• 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,Followup
• Report Date (Section B): 08/27/2021

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: SG3+2713
• Device Lot Number: 210215C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 06/28/2022
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/23/2021; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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