MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SYRINGE WITH SAFETY NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Codes	Bent (1059); Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device was not implanted.The actual device was disposed; however, an unused sample is available for return to the manufacturing facility.Therefore, the investigation was based upon evaluation of user facility information and retention samples of the involved product code/lot# combination.Based from the results of our investigation, the root cause of the complaint could not be identified.We have checked and verified the retention samples and confirmed free from any deformities such as bent, tilted and other damages on cannula which could result to broken needle.No holes, cracks, short shot or any molding related defects were also noted.Retention samples were further evaluated through sheath activation and deactivation and manual sheath activation.All samples had passed.We also conduct production in-process inspection, no nonconformity noted.Prior shipment, qc conducts outgoing inspection to assure lots are in good quality.All samples passed.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.
Event or Problem Description
The user facility reported the safety is not engaging when clicked.The nurse actually broke the needle when trying to get the safety to engage.The needle was flimsy and the safety doesn't always latch.Additional information received on 5/23/18: the needle was being used for a depo-provera shot.As the needle was being removed from the patient it had bent.Then when the nurse went to engage the safety the needle broke off.There was no needle stick, the needle just appeared to be flimsy and the safety did not latch.There was no impact to the patient or procedure as the patient received the intended dose of medication.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and to provide the completed investigation results.The unused samples have been returned to the manufacturing facility for evaluation.Same lot samples received consisted of 20 pieces unopened sg3 needles.The same lot samples visually inspected and confirmed free from any deformities which could result to broken needle.These samples were also evaluated through sheath activation and deactivation using autograph machine.All are within specification.They were also evaluated for cannula stiffness test and resistance to breakage test with passed results.In addition, sensory confirmation through manual activation are also passed.The cannula is fully engage and no broken cannula encountered during manual activation.Based on the results of our investigation, the root cause of the problem could not be identified since condition of the actual sample was not confirmed.There is no evidence that this event was related to a device defect or malfunction.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and to provide the completed investigation results.The unused samples have been returned to the manufacturing facility for evaluation.Same lot samples received consisted of 20 pieces unopened sg3 needles.The same lot samples visually inspected and confirmed free from any deformities which could result to broken needle.These samples were also evaluated through sheath activation and deactivation using autograph machine.All are within specification.They were also evaluated for cannula stiffness test and resistance to breakage test with passed results.In addition, sensory confirmation through manual activation are also passed.The cannula is fully engage and no broken cannula encountered during manual activation.Based on the results of our investigation, the root cause of the problem could not be identified since condition of the actual sample was not confirmed.There is no evidence that this event was related to a device defect or malfunction.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SYRINGE WITH SAFETY NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 7577697
• Report Number: 3003902955-2018-00027
• Device Sequence Number: 2629759
• Product Code: MEG
• UDI-Device Identifier: 30612479179128
• UDI-Public: 30612479179128
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 102-SN3C251S
• Device Lot Number: 170325A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1