MAUDE Adverse Event Report: IVA SEAL STERL 36MM RED 1000-B; CONTAINER, I.V.

Model Number	CP3009R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the material of the iva seal 36 mm foil seals for the cefuroxime dose vials caps has deteriorated.The foils cannot be removed from the top of the cap in one piece, as the stripping strip remains in the hand after which it is difficult to get the final foil off the cap.There has been no problem with that foil in the past.
Additional Manufacturer Narrative
There were no samples received with this complaint therefore an examination of the condition reported could not be made.From a root cause analysis perspective, the product is made to self-destruct when being removed from vials.There is a dual warning system in which seals self-destruct upon attempted removal, and needle punctures are highly visible in the laminated foil.This is to make it evident if the seal is tampered with.The slits on the seal help to ensure the product tears.Per the governing procedure for the product if upon peeling the iva seal from the container, there is evidence of the iva seal ripping, tearing, deforming or otherwise unusable.The results of the manufacturing facility investigation determined, based on the description received, the product worked as designed.No corrective or preventative actions are needed.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: IVA SEAL STERL 36MM RED 1000-B
• Common Device Name: CONTAINER, I.V.
• MDR Report Key: 12206133
• Report Number: 1219103-2021-00332
• Device Sequence Number: 14163058
• Product Code: KPE
• UDI-Device Identifier: 10884527006182
• UDI-Public: 10884527006182
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CP3009R
• Device Catalogue Number: CP3009R
• Device Lot Number: 912313X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1