MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-19 for SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP 864-1500-33 manufactured by Jms Singapore Pte Ltd.
[77822405]
(b)(4). (b)(6) report dated on 23 may 2017. Although we have established that the device did not cause or contribute to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 due to the blood loss (estimated blood loss around 750ml) encountered by the patient and 2 packed red blood cells transfused to the patient was admitted in icu. Since we do not know if there is any end-user error involved with the device, jms(b)(4) had conducted an investigation as a precaution if the device contributed to the adverse event. 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. 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 from facility, the dislodgment occurred half way through a four hour treatment. The nurse reported that there was no indication of needle malfunction or defect. They suspected that the venous needle dislodged from patient's access due to movement of patient. Jms was made aware that the machine involved in the event was reported as mdr to manufacturer and/or fda, however, due to confidential policies we cannot obtain those reports. 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, (vi) cannulation angle. Jms will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers.
Patient Sequence No: 1, Text Type: N, H10
[77822406]
On (b)(6) 2017, a hemodialysis (hd) patient (pt. ), ((b)(6), gender: male), was approximately half way through a four hour treatment (tx), when the venous needle became disconnected from the pt. And the pt. Lost "2 to 3 units of blood" and the blood loss was estimated by the nurse as approximately 750ml. The machine did not alarm. The facility is located in an acute unit at a hospital. The nurse reported that the pt. Would move his arm during the treatment and had to be reminded to keep it straight. While the nurse was tending to another pt. , another nurse noticed the blood coming from the pt. The nurse stated that it is assumed the pt was moving while the nurse was tending to other pts. The pt. Stated that he didn't feel good and vomited a small amount of bile but did not lose consciousness. The needle site was covered/occluded, treatment was discontinued, and the pt was transferred in the same hospital to the icu where the pt. Was transfused. The nurse reported that the pt. Was stable after the blood transfusion with 2 prbc. The pt has resumed his normal scheduled treatments. The nurse reported that the venous needle was a sysloc needle but did not know the lot or any other information and did not save the packaging and discarded the sample. The nurse also reported that there was no indication of a needle and/or bloodline malfunction or defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00002 |
| MDR Report Key | 6649411 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-19 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-05-01 |
| Date Facility Aware | 2017-05-23 |
| Report Date | 2017-05-24 |
| Date Reported to Mfgr | 2017-05-24 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2017-06-19 |
| 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 CHIA |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PK 1 |
| Manufacturer City | SINGAPORE 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer G1 | PT. JMS BATAM |
| Manufacturer Street | LOT 211 JALAN BERINGIN BATMINDO IND.PARK MUKA KUNING |
| Manufacturer City | BATAM KEPULAUAN RIAU, INDONESIA 29433 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 29433 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP |
| Generic Name | SYSLOC MINI AVF FISTULA NEEDLE SET, PRODUCT CODE: FIE,FOZ |
| Product Code | FIE |
| Date Received | 2017-06-19 |
| Model Number | 864-1500-33 |
| Lot Number | 161116321 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 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 PK 1 SINGAPORE 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-19 |