MAUDE Adverse Event Report: BAXTER HEALTHCARE- IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number J2C1009

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for sample evaluation.A visual inspection confirmed that the blue winged luer cap was damaged and had a hole at the tip of the cap which resulted in a leak.The cause of the reported condition was determined to be a manufacturing issue.A nonconformance has been opened to address this issue.Manufacturing awareness training for this issue was conducted on august 31, 2016.The complaint sample was manufactured in may 2016 which was prior to the manufacturing awareness training.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a leak from a crack in the winged cap of a large volume infusor during filling.There was no patient involvement.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE- IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6166146
• MDR Text Key: 62226598
• Report Number: 1416980-2016-18246
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: J2C1009
• Device Lot Number: 16E032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1