MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD; FISTULA NEEDLE PLUME SP - AV16M15SG P+

Model Number 862-2600

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/16/2018

Event Type  Death  

Manufacturer Narrative

On 27 jun 2019, jmss was informed by their europe counterparts (bionic) that there was a death case due to a dislodgement.And, bionic have confirmed that for this case, it was not a malfunction of the product.And, there's limited information and no further information can be obtained.The event was a dislodgement.The patient died.One of the used device was av16m15sgp+ (no lot number).Event happened in (b)(6).Event happened on (b)(6) 2018.Although the event has happened outside of us, jmss proceed for mdr reporting based on similar devices as stated in the "medical device reporting for manufacturers" guideline, point 4.11.3.Therefore, due to the lack of information on the actual defective lot, we are unable to conduct investigation and review for the reserved samples and dhr.Based on our complaint history and production database, none of the previously reported complaints were due to product problem or our manufacturing process.Additionally, per information provided by baxter via bionic, no defect or malfunction was observed of the reported defective sample and the dialysis machine was subject to the reported case.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 09 jul 2019 to all related operators and inspectors for their awareness on the reported defect.(b)(4).

Event Description

This is a case reported by mrs.(b)(6), communicated by phone to baxter (b)(4) on (b)(6) 2018.In the last quarter of 2018, whereas a needle plume, product code av16m15ssp and unknown lot number, this needle (probable the venous one) was dislodged from the patient's fistula.The patient is alleged to have died due to this dislodgement.No other information is available at the present time.

Manufacturer Narrative

On (b)(6) 2019 , jmss was informed by their europe counterparts (bionic) that there was a death case due to a dislodgement.And, bionic have confirmed that for this case, it was not a malfunction of the product.And, there's limited information and no further information can be obtained.[1] the event was a dislodgement.[2] the patient died.[3] one of the used device was av16m15sgp+ (no lot number).[4] event happened in france.[5] event happened on (b)(6) 2018.Although the event has happened outside of us, jmss proceed for mdr reporting based on similar devices as stated in the "medical device reporting for manufacturers" guideline, point 4.11.3.Therefore, due to the lack of information on the actual defective lot, we are unable to conduct investigation and review for the reserved samples and dhr.Based on our complaint history and production database, none of the previously reported complaints were due to product problem or our manufacturing process.Additionally, per information provided by baxter via bionic, no defect or malfunction was observed of the reported defective sample and the dialysis machine was subject to the reported case.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on (b)(6) 2019 to all related operators and inspectors for their awareness on the reported defect.Note: to change date of report from "(b)(6) 2019 ".

Event Description

This is a case reported by (b)(6) from the (b)(6), communicated by phone to baxter france on (b)(6) 2018.In the last quarter of 2018, whereas a needle plume, product code av16m15ssp and unknown lot number, this needle (probable the venous one) was dislodged from the patient's fistula.The patient is alleged to have died due to this dislodgement.No other information is available at the present time.This is a case reported by (b)(6) from the (b)(6), communicated by phone to baxter france on (b)(6) 2018.In the last quarter of 2018, whereas a needle plume, product code av16m15ssp and unknown lot number, this needle (probable the venous one) was dislodged from the patient's fistula.The patient is alleged to have died due to this dislodgement.No other information is available at the present time.

• Type of Device: FISTULA NEEDLE PLUME SP - AV16M15SG P+
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio industrial pk 1; singapore, 56962 0; SN 569620
• MDR Report Key: 8819895
• MDR Text Key: 152008123
• Report Number: 3002807350-2019-00003
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 862-2600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death