MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number RSP0516MFS

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).[conclusion]: 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 23 august 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: 1.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.2.The tear is a clean cut.This potentially indicates that the damage is a result of an object with a sharp, thin edge.3.The nylon material curls inward, indicating the tear was the result of a sharp object cutting the nylon from the outside.4.The tray was also nicked by the same sharp, thin object that cut the nylon.See attached images.5.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 foreign particle reported by the customer was noted during the visual inspection when the product was analyzed.The fourier-transform infrared spectroscopy (ftir) results indicate the foreign particle closely resembles cellophane, which is processed cellulose (e.G., paper, cardboard).This indicates the sharp object may have cut through the carton and the nylon pouch at the same time, resulting in a piece of the cardboard carton falling through the cut in the nylon.Based on review of the shipping and distribution process, there are in-process inspections in place to prevent this type of defect from leaving the manufacturing facility.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 5MM, 5PK
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7855724
• MDR Text Key: 119658816
• Report Number: 3005172759-2018-00112
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232839
• UDI-Public: 10705031232839
• Combination Product (y/n): N
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Catalogue Number: RSP0516MFS
• Device Lot Number: 180307B-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1