MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV 105ADMIN SET 20DP, W/2 Y SITE, CV CLMPS; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70072
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 105admin set 20dp, w/2 y site, cv clmps had back flow issues.This occurred on 7 occasions.The following information was provided by the initial reporter: material no: b2-70072 batch(lot) no: 19105051.It was reported that administration sets had back flow issues.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07/15/2020.E1:contact information for initial reporter was update to (b)(6).E3.Occupation: quality assurance engineer.G3: report source: user facility, other.G3: quality assurance engineer.Investigation summary: a review of the device history record was performed.Bd product model: b2-70072, reported lot number: 19105051.Gravity testing was conducted by cad sd on the three b2-70072, with the primary sets primed with water, and the secondary sets primed with blue-dye water, upon clamping the primary set, backflow was observed in all the sets, confirming the failure mode.The valve check reported was manufactured at a supplier site.Therefore, a formal investigation was requested to the supplier: the complaint was acknowledged by filterleak on aug/05/2020.When the complaint was received filtertek newcastle west was closed for summer shutdown.Plant reopened on aug/18/2020.Part number: 8300219, lot: 20706 was produced, in filtertek newcastle west from jul/10/2018 to jul/26/2018.The entire lot quantity, (b)(4) parts were shipped to itw medical hebron for later shipment to bd.The batch record no issues noted as part of the manufacture or qc testing of lot: 20706.Five retained parts from the start-up of the lot were backflow tested ¿ all passed; no previous complaints received for lot: 20706.The samples were delivered by fedex on (b)(6) 2020.The returned check valves were included in sets numbered b1, b2 & b3.Sample b1: the check valve failed to shut off when a secondary iv line was introduced, fluid was seen to travel from the secondary line back through the check valve, conforming bd¿s reported backflow leak.On removing the valve from the set a manual backflow test and opening pressure test were completed, the valve failed the backflow test (fast leak) and the opening pressure was low at 2 cmwg.Sample b2: the check valve prevented a backflow from occurring when a secondary iv line was introduced.On removing the valve from the set a manual backflow test and opening pressure test were completed, the valve passed the backflow test and the opening pressure was 7 cm.The valve was sectioned, and the internals were clean.Sample b3: b3: the check valve prevented a backflow from occurring when a secondary iv line was introduced.On removing the valve from the set a manual backflow test and opening pressure test were completed, the valve passed the backflow test and the opening pressure was 6 cm.The valve was sectioned and the internals were clean.The backflow issues found in sample b2 & b3 could not be replicated in filtertek.The issue was replicated by filtertek and translucent particles were found in the part b1 when it was sectioned.Although it cannot be confirmed that the translucent particles were the cause of the backflow, they were found in the part with the backflow and not in the two other returned parts.There are no sources of starch used in the filtertek manufacturing process.As no conclusive root cause has been found there no actions applicable at this time.
Event or Problem Description
It was reported that 105 admin set 20dp, w/2 y site, cv clmps had back flow issues.This occurred on 7 occasions.The following information was provided by the initial reporter: material no: b2-70072, batch (lot) no: 19105051.It was reported that administration sets had back flow issues.

• Brand Name: 105ADMIN SET 20DP, W/2 Y SITE, CV CLMPS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10242928
• Report Number: 9616066-2020-02190
• Device Sequence Number: 2485881
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 814371020198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 19105051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20200603.; 20200603.
• Outcome Attributed to Adverse Event: Other