MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number	11426964
Medical Device Problem Codes	Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a complaint of foreign matter was received from the customer.Two samples was received for investigation and through visual inspection of the sample black foreign matter was found around the spike.The customer's complaint was verified.A device history record review for model 11426964 lot number 20077096 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 25jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: two samples were received for investigation.Through visual inspection there was black foreign matter found on the spike of both samples (p/n:11621574) when the cap was removed.When touched the black matter did wipe off, so it was not embedded in the material of the spike.Root cause description: the root cause for this failure was found to be error in the manufacturing process.This incident has been added to our database of reported incidents.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that black foreign matter, possibly thought to be mold, was found on the as lvp 20d low sorb.The following information was provided by the initial reporter: today one of our pharmacy techs noticed something black on one of our tubing sets when he removed the cap.We found one other set with the same issue.This is on the bd alaris pump infusion set ref 11426964.I am not positive on the lot number as these were removed and prepped for chemotherapy administration earlier in the day and the packaging was discarded.The lot# i have on the shelf is (10)20077096.We have looked at all the other sets that we have and haven¿t found any others with this issue.It is hard to tell if this is some sort of manufacturing defect or some kind of growth.
Additional Manufacturer Narrative
H.6.Investigation: two samples was received for investigation and through visual inspection of the sample black foreign matter was found around the spike.The customer's complaint was verified.A device history record review for model 11426964 lot number 20077096 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this failure was found to be error in the manufacturing process.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot #20077096 regarding item #11426964.H3 other text : see h.10.
Event or Problem Description
It was reported that black foreign matter, possibly thought to be mold, was found on the as lvp 20d low sorb.The following information was provided by the initial reporter: today one of our pharmacy techs noticed something black on one of our tubing sets when he removed the cap.We found one other set with the same issue.This is on the bd alaris pump infusion set ref 11426964.I am not positive on the lot number as these were removed and prepped for chemotherapy administration earlier in the day and the packaging was discarded.The lot# i have on the shelf is (10)20077096.We have looked at all the other sets that we have and haven¿t found any others with this issue.It is hard to tell if this is some sort of manufacturing defect or some kind of growth.

• Brand Name: AS LVP 20D LOW SORB
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10775123
• Report Number: 9616066-2020-20234
• Device Sequence Number: 14424056
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: 50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 07/25/2023
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: 20077096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1