MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for NIPRO STANDARD AVF NEEDLE AV1625HTC30R UNKNOWN manufactured by Nipro (thailand) Corp. Ltd..
[146490128]
On (b)(6) 2019: initial investigation report attached is on retained samples only. Final investigation on returned samples is still pending. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[146490129]
Patient had been dialyzing on a bed for approximately 35 minutes and complained of feeling unwell; patient's fistula arm was covered by a thick blanket despite company policy to the contrary. Patient was hypotensive, ashen and clammy. The blanket was removed from fistula arm and staff found that approximately 300 - 400ml of blood leaked and stained the patient's sheet. Nurse in attendance disconnected the blood line from the venous needle; in order to give normal saline directly to the patient, and noticed a leak from the fistula needle hub. Patient's blood was returned through their arterial needle. Patient's hemoglobin was high (around 12g/dl) pre-treatment and has recovered well. Customer confirmed that the patient was assessed prior to treatment and no issues were noted at the time of connection. Staff also confirmed that the dialysis machine did not alarm at any point during treatment and patient has returned for their next regular scheduled treatment without further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2019-00003 |
| MDR Report Key | 8593234 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2018-12-08 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE TEJADA |
| Manufacturer Street | 3150 NW 107 AVENUE |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 3055997174 |
| Manufacturer G1 | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Street | 10/2 MOO 8, BANGNOMKO, SENA |
| Manufacturer City | AYUTHAYA,?, 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NIPRO STANDARD AVF NEEDLE |
| Generic Name | AVF NEEDLE |
| Product Code | FIE |
| Date Received | 2019-05-08 |
| Model Number | AV1625HTC30R |
| Catalog Number | UNKNOWN |
| Lot Number | 18L08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA,?, 13110 TH 13110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-08 |