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

Model Number N/A

Device Problems Bent (1059); Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

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.(b)(4).

Event 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.

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.

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
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 7577697
• MDR Text Key: 110465050
• Report Number: 3003902955-2018-00027
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479179128
• UDI-Public: 30612479179128
• Combination Product (y/n): N
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1