MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SYRINGE; SYRINGE, PISTON

Model Number N/A

Device Problems Break (1069); Material Fragmentation (1261); Melted (1385); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Udi - not required for the reported product code/lot number combination.The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and retention samples of the involved product/lot number combination.Visual inspection revealed no defects.A review of the lot history files was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual, dimensional, and functional testing and all samples for the complaint lot passed.All syringes are compliant to iso 594-2.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause cannot be definitely determined.(b)(4).Patient, device, method, results, and conclusions codes are unable to be selected at this time.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.

Event Description

The user facility reported that the syringe broke.The following information was provided by the user facility: patient due for hemofiltration therapy.Vascath inserted.Prior to connecting vascath to hemofiltration set the 20 cc syringe was connected to the vascath lumen and blood aspirated to assess patency and blood flow.Tip of 20 cc syringe broke off within the vascath lumen rendering it unable to be used.When attempting to remove broken syringe tip from the vascath, it was noted to be "too soft and breaking / melting into pieces".Vascath had to be removed and another vascath inserted.Details of injury (to patient, carer or healthcare professional): delayed treatment.Removal of vascath and reinsertion of second vascath prior to treatment commencing.Increased risk to patient of removal and reinsertion of vascath.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).Vascath lumen clamped immediately.Medical team and senior nurse informed.Attempts to remove broken syringe tip unsuccessful.Vascath removed.Second vascath inserted.

Manufacturer Narrative

The actual 20 ml syringe sample was received for evaluation.The following was observed: an unblistered 20 ml terumo syringe with no needle attached to it, was noted to have a broken tip; blood stains were noted on the syringe tip; and the sample evidently showed that too much force was applied during usage.Based on the investigation, the actual sample showed too much force was possibly applied during usage that may have caused the breakage of syringe tip.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).Exemption number e2015017.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, reg. no. 3003902955 ; RP
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6881300
• MDR Text Key: 86989128
• Report Number: 3003902955-2017-00031
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: SS+20L1
• Device Lot Number: 151111B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention