MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP; JMS WINGEATER A.V.FISTULA NEEDLE SET

Model Number 820-5002-33

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Expulsion (2933)

Patient Problems Cardiopulmonary Arrest (1765); Hypovolemia (2243); Blood Loss (2597)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Our manufacturing process was within control and no abnormality was found on the given product lot.The product lot met all the qa outgoing inspection criteria prior releasing to the market.Based on the results of reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out for reported lot 180823351.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.As per information provided by facility and jmsna, there were no product problems before, during or after use with venous needle.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on (b)(4) 2019 on all related operators and inspectors for their awareness on the reported defect.(b)(4).

Event Description

On (b)(6) 2018, a hemodialysis patient, arrived to treatment alert and orientated.Pre-dialysis vital signs obtained: b/p: 152/77; pulse 73; resp 20; temp: 97.6.Treatment was initiated at 13:21, and vs checked every 20 minutes.At 14:01, b/p was 128/68; pulse 75.Approximately 8 minutes later, the machine alarmed.The patient was found unresponsive with the tip of the venous needle dislodged.Tape was still intact on the patient's skin.Large amounts of blood were noted on the floor.Ebl 300-400 ml.The venous line was clamped and pressure applied to the venous cannulation site.Blood was returned via the arterial needle, and normal saline was administered via the arterial needle; approximately 800 ml normal saline was administered.Oxygen was applied via mask at 3 lpm; aed pads placed on chest; cpr initiated.911 was called.The patient started spontaneously breathing at 14:13.Vs upon discharge from facility: b/p 156/99; pulse 102; resp 23; temp 97.8.The patient was transported to the hospital via ems and admitted.Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019.

Manufacturer Narrative

Exemption number: e2010016.(b)(4).Our manufacturing process was within control and no abnormality was found on the given product lot.The product lot met all the qa outgoing inspection criteria prior releasing to the market.Based on the results of reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out for reported lot 180823351.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.As per information provided by facility and (b)(4), there were no product problems before, during or after use with venous needle.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 15 jan 2019 on all related operators and inspectors for their awareness on the reported defect.This submission has been resubmitted due to revised date format in describe event or problem from "the patient was transported to the hospital via ems and admitted.Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019" to "the patient was transported to the hospital via ems and admitted.Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019." (b)(4).

Event Description

On (b)(6) 2018, a hemodialysis patient, arrived to treatment alert and orientated.Pre-dialysis vital signs obtained: b/p: 152/77; pulse 73; resp 20; temp: 97.6.Treatment was initiated at 13:21, and vs checked every 20 minutes.At 14:01, b/p was 128/68; pulse 75.Approximately 8 minutes later, the machine alarmed.The patient was found unresponsive with the tip of the venous needle dislodged.Tape was still intact on the patient's skin.Large amounts of blood were noted on the floor.Ebl 300-400 ml.The venous line was clamped and pressure applied to the venous cannulation site.Blood was returned via the arterial needle, and normal saline was administered via the arterial needle; approximately 800 ml normal saline was administered.Oxygen was applied via mask at 3 lpm; aed pads placed on chest; cpr initiated.911 was called.The patient started spontaneously breathing at 14:13.Vs upon discharge from facility: b/p 156/99; pulse 102; resp 23; temp 97.8.The patient was transported to the hospital via ems and admitted.Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019.

Manufacturer Narrative

Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of jmsna (importer).Our manufacturing process was within control and no abnormality was found on the given product lot.The product lot met all the qa outgoing inspection criteria prior releasing to the market.Based on the results of reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out for reported lot: 180823351.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.As per information provided by facility and jmsna, there were no product problems before, during or after use with venous needle.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 15 jan 2019 on all related operators and inspectors for their awareness on the reported defect.

Event Description

On (b)(6) 2018, a hemodialysis patient, arrived to treatment alert and orientated.Pre-dialysis vital signs obtained: b/p: 152/77; pulse 73; resp 20; temp: 97.6.Treatment was initiated at 13:21, and vs checked every 20 minutes.At 14:01, b/p was 128/68; pulse 75.Approximately 8 minutes later, the machine alarmed.The patient was found unresponsive with the tip of the venous needle dislodged.Tape was still intact on the patient's skin.Large amounts of blood were noted on the floor.Ebl 300-400 ml.The venous line was clamped and pressure applied to the venous cannulation site.Blood was returned via the arterial needle, and normal saline was administered via the arterial needle; approximately 800 ml normal saline was administered.Oxygen was applied via mask at 3 lpm; aed pads placed on chest; cpr initiated.911 was called.The patient started spontaneously breathing at 14:13.Vs upon discharge from facility: b/p 156/99; pulse 102; resp 23; temp 97.8.The patient was transported to the hospital via ems and admitted.Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged on (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019.

• Brand Name: WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP
• Type of Device: JMS WINGEATER A.V.FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio industrial pk 1; singapore, 56962 0; SN 569620
• MDR Report Key: 8269836
• MDR Text Key: 133839532
• Report Number: 3002807350-2019-00001
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (y/n): N
• PMA/PMN Number: K111948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019,01/09/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 820-5002-33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/16/2019; 01/16/2019
• Supplement Dates FDA Received: 01/23/2019; 01/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Weight: 62