MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD PCA SET Y CONN CHECK VLV 90 INCH; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30873
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd pca set y conn check vlv 90 inch leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: the ivf was leaking out of the port that connects it to the pca tubing.Changed the primary fluid tubing and it was still leaking.We decided that we needed to change the pca tubing.After we changed the pca tubing we had no more leaking.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-oct-2022.H6: investigation summary the customer reported the tubing was leaking and returned one used sample of material 30873.The sample had a crack in the male luer, the whole length of the luer post.The complaint of leakage at the connection is verified.The root cause is unknown, but is not believed to related to manufacturing or a bd process.This could potentially be an end user issue, with overtightening of the luer, but this root cause cannot be confirmed.A device history record review could not be performed on material 30873 because the lot number is unknown.
Event or Problem Description
It was reported while using bd pca set y conn check vlv 90 inch leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: the ivf was leaking out of the port that connects it to the pca tubing.Changed the primary fluid tubing and it was still leaking.We decided that we needed to change the pca tubing.After we changed the pca tubing we had no more leaking.

• Brand Name: BD PCA SET Y CONN CHECK VLV 90 INCH
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15764796
• Report Number: 9616066-2022-01699
• Device Sequence Number: 15511164
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: 10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/15/2022

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 Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown