MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD SYSLOC MINI AVF 14GX1" BE 30CM W/CLAMP; MPB, FOZ, FIE

Model Number 864-1400-33

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Clinic's initial report: clinic initially reported "patient yelled from across the room that he was bleeding out from venous site.Needle was in place with tape secured.The tube broke off into two separate pieces.Blood returned through arterial site needle from access removed.Wing eater not attached to needle.All foreign objects accounted for." clinic's additional information: centre manager advised that there was no medical intervention provided to patient and the blood loss was estimated to be more than 1500cc.In the initial report, the clinic mentioned a term "wingeater".Based on (b)(4)'s telephone interview with the clinic manager, the centre manager confirmed that they referred the term "wingeater" to "needle and wing assembly of sysloc".Moreover, the centre manager clarified that tube separated at wing and needle wing assembly remained in access where it gushed blood.(b)(4) wish to clarify that (b)(4) has a product called "wingeater" and the facility also uses wingeater, but the wingeater product was not used on this patient.After interviewing with the centre manager it was confirmed that the blood loss was ~ 400-500cc.

Manufacturer Narrative

(b)(4).(the manufacturer) is submitting the report on behalf of (b)(4) (the importer)".Although we have not established that the device caused or contributed to the event, we are reporting it out of caution to be in compliance with 21cfrpart803.We cannot rule out causality.From reserved sample evaluation and device history record review, there was no abnormality found and the complaint lot met the qa specifications prior releasing it to the market.As there was no returned sample, we could not confirm on the actual root cause.Nevertheless, we have implemented corrective actions on the suspected possible causes.We will continue to monitor this defect trend from our manufacturing and from the market.Lastly, (b)(4) will continue to maintain good quality of our products and ensure that only good quality products will be delivered to customers.Device not returned to manufacturer.

• Brand Name: SYSLOC MINI AVF 14GX1" BE 30CM W/CLAMP
• Type of Device: MPB, FOZ, FIE
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio; industrial park i; singapore, singapore 56962 0; SN 569620
• Manufacturer (Section G): JMS SINGAPORE PTE LTD; 440 ang mo kio; industrial park i; singapore, singapore 5696 20; SN 569620
• Manufacturer Contact: koh seng ; 440 ang mo kio industrial park; singapore, singapore 56962-0 ; SN 569620 ; 6457 1144
• MDR Report Key: 3699788
• MDR Text Key: 4230098
• Report Number: 3002807350-2014-00003
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2014,03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2016
• Device Model Number: 864-1400-33
• Device Lot Number: 110825611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2014
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 02/26/2014
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2011
• 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): Other
• Patient Age: 48 YR
• Patient Weight: 168