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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FORTE 8CM; SPLINT, INTRANASAL SEPTAL
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STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FORTE 8CM; SPLINT, INTRANASAL SEPTAL Back to Search Results
Catalog Number ND02-025/08 C
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that the sterile seal was breached prior to use.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
H6; the nasopore product and packaging reported involved in this event was returned for evaluation.On receipt of the product and packaging the reported malfunction of an open(compromised) package seal was confirmed.The product and packaging was evaluated by the product packaging engineer who concluded that the packaging seal is open at one end of the package (approx.25% open) (chevron end).Seal integrity has been breached.There is evidence of seal transfer are there in the blister and tyvek.There is no obvious damage to the device or blister package.The seal transfer indicates that the package was sealed at some point.The amount of seal transfer indicates that there was likely to have been a good seal in place at time of manufacture.The root cause of this event is undetermined.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that the sterile seal was breached prior to use.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
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Brand Name
NASOPORE FORTE 8CM
Type of Device
SPLINT, INTRANASAL SEPTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10563618
MDR Text Key208414584
Report Number0001811755-2020-02419
Device Sequence Number1
Product Code LYA
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2021
Device Catalogue NumberND02-025/08 C
Device Lot NumberNDA2020041612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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