MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-29 for AVF SYSLOC MINI 15G X 1" BE 30CM W/CLAMP 864-1500-33 manufactured by Jms Singapore Pte Ltd.
[61084538]
(b)(4). Jmss (manufacturer) is submitting the report on behalf of (b)(4) (importer). Jmss is reporting this case as mdr because of the blood loss (~100ml to 130ml) encountered by the patient and the patient was administered with nearly 100ml natural saline bolus as fluid replacement. Based on our reserve sample evaluation and device history record of the reported lot 160426321, 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. As per the design of the device, the needle cannot be retracted into the safety feature (blue wing) if the external lock is capped. External lock is uncapped only during retraction of the needle. Based on the clinic manager's feedback, the technician conducted a brief glance on the external lock before cannulation and could not recalled if there was any uncapped external lock. She only recalled that it was uncapped as the needle migrated into wing. Hence, there might be a possibility that the patient might have moved or might have accidentally uncapped the external lock causing the needle to retract inside the wing or the needle set or blood lines might have caught on something which caused the external lock to be uncapped accidentally and causing the needle to retract inside the wing. The following precautionary statement is stated in our instruction for use under clause 4, to caution user on the correct method of handling external lock "do not unlock the device prior to cannulation because it is difficult to lock back if it is not centered properly. Visual inspection of locking mechanism should be done prior to cannulation. Tug slightly on the tubing to ensure that the lock is engaged". Thus, no corrective action will be applicable as reported incident is not related to any malfunction of jmss product. From october 2013 to mar 2016, about (b)(4) sets were manufactured and distributed worldwide with no such defect occurred in the market. Thus, we believe that this incident might be a spot occurrence of accidental movement or end-user usage issue. Jmss will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers. We will continue to work with our customers to improve our products quality.
Patient Sequence No: 1, Text Type: N, H10
[61084539]
Initial report: ms, (b)(6) and patient noted bleeding from vascular access site, noted needle clamp was open and needle was apparently engaging in safety devise. As ms, (b)(6) attempted to assess situation, needle became fully engaged in safety devise and patient bled from vascular access site. Additional information: specific to this incident, reporter stated that the technician alerted her that the clasp was undone and needle was moving into safety device. Post-incident the manager asked the technician if she had unlatched the clasp and re-latched and the technician said no*. *there was some internal learning curve issues as they transitioned to using sysloc mini approximately a year ago. During that period, some technicians gave feedback that since the 'bevel does not come aligned with wings' they have to unlatch and re-latch to rotate the needle or align the bevel for cannulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2016-00012 |
| MDR Report Key | 6133973 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-28 |
| Date of Event | 2016-10-20 |
| Date Facility Aware | 2016-11-01 |
| Report Date | 2016-11-02 |
| Date Reported to Mfgr | 2016-11-02 |
| Date Mfgr Received | 2016-11-02 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2016-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHIN YIN CHIA |
| Manufacturer Street | 440, ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer Phone | 71176 |
| Manufacturer G1 | JMS SINGAPORE PTE LTD |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 569620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVF SYSLOC MINI 15G X 1" BE 30CM W/CLAMP |
| Generic Name | A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2016-11-29 |
| Model Number | 864-1500-33 |
| Lot Number | 160426321 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PARK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-29 |