MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-07 for RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK RSP0516MFS manufactured by Acclarent, Inc..
[119658816]
(b)(4). On (b)(6) 2018, the healthcare professional reported that there was a tear in the packaging of the relieva spinplus, 5mm 3 guides kit (rsp0516mfs / 180307b-pc) and a little piece of what appeared to be cardboard was inside the packaging. The spinplus balloon kit was not used for the procedure. There was no report of any patient consequence or adverse event associated with the issue as another balloon kit was opened and used for the procedure. Acclarent received the returned package on (b)(6) 2018 that included the relieva spinplus device and three guide catheters (s-0, f-70, and m-110). Before undergoing decontamination, the package was visually inspected. A tear was observed on the package and a particle that appears to look like a piece of cardboard was inside. The following observations were made during the visual inspection of the device packaging: the tear is on the nylon side of the package, located in the middle top region of the pouch. It is away from all in-house and manufacturing seals. The tear is a clean cut. This potentially indicates that the damage is a result of an object with a sharp, thin edge. The nylon material curls inward, indicating the tear was the result of a sharp object cutting the nylon from the outside. The tray was also nicked by the same sharp, thin object that cut the nylon. See attached images. The issue is unlikely to have happened during the manufacturing process at acclarent since all devices are manufactured and packaged in accordance with documented specifications and procedures and passed all required release criteria. In addition, in-process inspections are in place to prevent this type of defect prior to leaving the facility. The lot history record(s) was reviewed for lot 180307b-pc; no anomalies were found related to this complaint. In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures. With the information provided in the complaint and the observations made on the returned device, the reported issue that a tear was observed on the packaging of the device was confirmed. The most likely cause of the reported tear is due to a sharp object cutting the nylon from the outside; the sharp object also caused a nick on the molded plastic tray that contains the device. Shipping and handling may also be contributing factors to the reported issue. Based on the lot history record review, there is no indication that the event is related to the device manufacturing process. All devices are manufactured and packaged in accordance with documented specifications and procedures and passed all required release criteria. In addition, in-process inspections are in place to prevent this type of defect prior to leaving the facility. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
[119658817]
On (b)(6) 2018, the healthcare professional reported that there was a tear in the packaging of the relieva spinplus, 5mm 3 guides kit (rsp0516mfs / 180307b-pc) and a little piece of what appeared to be cardboard was inside the packaging. The spinplus balloon kit was not used for the procedure. There was no report of any patient consequence or adverse event associated with the issue as another balloon kit was opened and used for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00112 |
| MDR Report Key | 7855724 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2018-03-07 |
| Date Added to Maude | 2018-09-07 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-09-07 |
| Returned To Mfg | 2018-08-23 |
| Catalog Number | RSP0516MFS |
| Lot Number | 180307B-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |