MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	42521E
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20025895, medical device expiration date: 2023-02-17,.Device manufacture date: 2020-02-11.Medical device lot #: 20046529, medical device expiration date: 2023-04-29, device manufacture date: 2020-04-20.(b)(4).Investigation summary: a dhr was performed on possible lots 20025895 and 20046529.A device history record review for model 42521e lot number 20025895 was performed.The search showed that a total of 5763 units in 1 lot number was built on 18feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 42521e lot number 20046529 was performed.The search showed that a total of 5763 units in 1 lot number was built on 29apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: one photo was returned by the customer which does not verify the customer complaint.The customer complaint that the tubing would not prime and appears to be blocked where it attaches to the drip chamber could not be verified due to the product not being returned for failure investigation.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
Event or Problem Description
It was reported that the gra 15dp ckv 3ss w/2 4w stpck dehp free tubing would not prime during use.The following information was provided by the initial reporter: "these tubings would not prime.I clamped the tubing, attached a syringe to the most proximal hub to the drip chamber and tried to pull fluid forward and only got resistance.It appears as if the tubing is blocked where it attaches to the drip chamber." "the tubing had been spiked into an iv bag however never in a patient room.".

• Brand Name: GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE
• 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: 11181343
• Report Number: 9616066-2021-50065
• Device Sequence Number: 19581818
• Product Code: FPA
• UDI-Device Identifier: 50885403274259
• UDI-Public: 50885403274259
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 01/08/2021

1 Device 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: 42521E
• Device Catalogue Number: 42521E
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No