MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	30262E
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown (b)(4).
Event or Problem Description
It was reported that 40 inch ext w/2 vlv ports was difficult to disconnect.The following information was provided by the initial reporter: material no.: mz9267 batch no.: unknown it was reported the maxzero is difficult to disconnect; it was fused into the smartsite of the alaris extenstion set 30262e after cleaning with chg/alcohol.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that 40 inch ext w/2 vlv ports was difficult to disconnect.The following information was provided by the initial reporter: material no.: mz9267 batch no.: 20056291 it was reported the maxzero is difficult to disconnect; it was fused into the smartsite of the alaris extenstion set 30262e after cleaning with chg/alcohol.D.4.Medical device lot#: 20066847 h.6.Investigation: a device history record review for model 30262e lot number 20066847 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A sample was not returned for this model# and the complaint could not be confirmed.See h.10.
Event or Problem Description
It was reported that 40 inch ext w/2 vlv ports was difficult to disconnect.The following information was provided by the initial reporter: material no.: mz9267 batch no.: 20056291 it was reported the maxzero is difficult to disconnect; it was fused into the smartsite of the alaris extenstion set 30262e after cleaning with chg/alcohol.

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• 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: 10665647
• Report Number: 9616066-2020-20056
• Device Sequence Number: 3655971
• Product Code: FPA
• UDI-Device Identifier: 37613203011489
• UDI-Public: 37613203011489
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: Other
• Device Model Number: 30262E
• Device Catalogue Number: 30262E
• Device Lot Number: 20066847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other