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

Model Number	864-1500-33
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of jmsna (importer).Although we have established that the device did not caused or contributed to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 related to 1000ml normal saline was administered on patient due to blood loss of estimated 1000cc and patient was transferred to the emergency room.Based on our reserve sample evaluation and device history record of the lot number provided by the clinic, there was no abnormality found.The products met the qa specifications prior releasing it to the market.There was no reported or detected malfunction on the needle itself.Due to unavailability of actual sample involved in the event, we are unable to verify the actual cause of the reported claim.Based on the unused returned sets, there was no abnormality found.Although we could not establish causal effect (either use error or product defect), we did due diligence and investigated the reported lot, in an effort to further substantiate that there is no abnormality observed in our products.Based on the information provided by user facility, they saw no defects with the sysloc mini or the external lock area.The internal investigation into suspected cause had shown that it was either patient movement (unknown if voluntary or involuntary) or unknown cause.Causal analysis reveals that the reported adverse event incidents could be due to some other possible factors that results in the dislodgment of the needle set, poor quality of tape / poor adhesion strength of the tape, gravitational pull on the avf needle set, disinfectant / lotion / medication used on the patient, patient's perspiration, patient's skin condition.[(b)(4)].
Event or Problem Description
From (b)(6).Nurse reported a sysloc mini lock fistula set, which disengaged during treatment.Patient was in 3rd hour of treatment, after blood pressure check and blanket was moved, the sysloc mini became disengaged and needle was retracted into hub.From (b)(6).Three hours into a 4 hour tx pt c/o feeling bad asked for bp result.Pt then wanted bs taken.Pt was with acute blood loss from needle that had retracted into safety device.Venous needle was found with dressing intact & blood pouring up above venous needle pt was given normal saline & blood pump stopped pressure held.Sent to er with stable blood pressure & alert & oriented for evaluation.Additional information from complaint report.User facility explained that external lock on wing of sysloc mini came undone after blood pressure check.They are uncertain exactly how, as they did not see the blanket snag on the external lock.They do know that the blanket was covering the access site.No tube entanglement suspected but after bp check at approx.12:35pm (e.D.T) blanket was used by patient in access area unknown if it snagged on anything at all as it did not appear to during checks.Patient's treatment history for hd is that she is very compliant with treatments, staff and is not known for excess or exaggerated movements.Estimated blood loss is 1000cc.Fluid replacement was natural saline bolus of nearly entire quantity of 1000cc.They know their staff did not latch and then re-latch the sysloc mini in-use.They saw no defects with the sysloc mini or the external lock area.User facility administrator opened 3 sysloc mini sets and looked closer at the external lock.They pulled the entire lot from use.
Event or Problem Description
From fmc-na.Nurse reported a sysloc mini lock fistula set, which disengaged during treatment.Patient was in 3rd hour of treatment, after blood pressure check and blanket was moved, the sysloc mini became disengaged and needle was retracted into hub.From fkc morgan county jv.3 hours into a 4 hour therapy patient complained of feeling bad asked for blood pressure result.Patient then wanted blood sample taken.Patient was with acute blood loss from needle that had retracted into safety device.Venous needle was found with dressing intact & blood pouring up above venous needle.Patient was given normal saline & blood pump stopped pressure held.Sent to emergency room with stable blood pressure & alert & oriented for evaluation.Additional information from complaint report.User facility explained that external lock on wing of sysloc mini came undone after blood pressure check.They are uncertain exactly how, as they did not see the blanket snag on the external lock.They do know that the blanket was covering the access site.No tube entanglement suspected but after bp check at approx.12:35pm (e.D.T) blanket was used by patient in access area unknown if it snagged on anything at all as it did not appear to during checks.Patient's treatment history for hemodialysis is that she is very compliant with treatments, staff and is not known for excess or exaggerated movements.Estimated blood loss is 1000cc.Fluid replacement was natural saline bolus of nearly entire quantity of 1000cc.They know their staff did not latch and then re-latch the sysloc mini in-use.They saw no defects with the sysloc mini or the external lock area.User facility administrator opened 3 sysloc mini sets and looked closer at the external lock.They pulled the entire lot from use.
Additional Manufacturer Narrative
Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of jmsna (importer).Although we have established that the device did not caused or contributed to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 related to 1000ml normal saline was administered on patient due to blood loss of estimated 1000cc and patient was transferred to the emergency room.Based on our reserve sample evaluation and device history record of the lot number provided by the clinic, there was no abnormality found.The products met the qa specifications prior releasing it to the market.There was no reported or detected malfunction on the needle itself.Due to unavailability of actual sample involved in the event, we are unable to verify the actual cause of the reported claim.Based on the unused returned sets, there was no abnormality found.Although we could not establish causal effect (either use error or product defect), we did due diligence and investigated the reported lot, in an effort to further substantiate that there is no abnormality observed in our products.Based on the information provided by user facility, they saw no defects with the sysloc mini or the external lock area.The internal investigation into suspected cause had shown that it was either patient movement (unknown if voluntary or involuntary) or unknown cause.Causal analysis reveals that the reported adverse event incidents could be due to some other possible factors that results in the dislodgment of the needle set (i) poor quality of tape / poor adhesion strength of the tape, (ii) gravitational pull on the avf needle set, (iii) disinfectant / lotion / medication used on the patient, (iv) patient's perspiration, (v) patient's skin condition.This submission has been resubmitted due to abbreviations in 5.(b)(4).

• Brand Name: SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP
• Common Device Name: JMS SYSLOC MINI 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: 7559601
• Report Number: 3002807350-2018-00005
• Device Sequence Number: 19161939
• Product Code: FIE
• UDI-Device Identifier: 08888483005567
• UDI-Public: 08888483005567
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 864-1500-33
• Device Lot Number: 171114321
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2018
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 122