MAUDE Adverse Event Report: ADMIN SET 20DP W/ FILTER Y SITE CLMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70071-DF
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21045386.Medical device expiration date: 2024-04-03.Device manufacture date: 2021-04-03.Medical device lot #: 21045387.Medical device expiration date: 2024-04-03.Device manufacture date: 2021-04-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 admin set 20dp w/ filter y site clmp were not sterile.The following information was provided by the initial reporter: material no: b2-70071-df.Batch no: 21045386, 21045387.The products did not meet the sterilization specification.The certificate of processing was approved without noticing the issue.It is not a typo error in the paperwork.The certificate of processing indicated that the vessel processing time of eto sterilization was out of specification.I would think it is a sterilization failure.
Additional Manufacturer Narrative
H.6.Investigation: it was reported that the products did not meet the sterilization specification.During the review of cos, the customer found that the vessel processing time for load 26264 was 6.78h, which was outside of the specification 8h± 10% (from 7.2h to 8.8h) as defined in ethylene oxide customer specification zyn-761, revision 5.Upon notification bd product release team proceed to place the material on hold and contact steris temecula for further investigation.The vessel cycle print out was reviewed finding that the cycle elapsed time in the certificate of processing was manual entry error, the actual cycle elapsed time was 7 hours and 46 minutes or 7.78hours (attached #1) which is within the allowed range of 7.2-8.8 hours.Root cause definition: after the revision it was determinate that the product release team failed to review the cycle total elapsed time since procedure 0803-005-000-swi documentation review of sterile disposables infusion products does not list the cycle total elapsed time as characteristic to review on the certificates of processing, therefore, the failed review of the cycle total elapsed time was considered as the root cause.Dhr was performed and no qn's were found for the reported lots.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 admin set 20dp w/ filter y site clmp were not sterile.The following information was provided by the initial reporter: material no: b2-70071-df.Batch no: 21045386, 21045387.The products did not meet the sterilization specification.The certificate of processing was approved without noticing the issue.It is not a typo error in the paperwork.The certificate of processing indicated that the vessel processing time of eto sterilization was out of specification.I would think it is a sterilization failure.

• Brand Name: ADMIN SET 20DP W/ FILTER Y SITE CLMP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11882887
• Report Number: 9616066-2021-51153
• Device Sequence Number: 16497354
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: Other
• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1