MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pulmonary Hypertension (4460)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the customer received a spike in complaints from patients related to leaky extension set with male/male luer, 0.2-micron air-eliminating filter, integral anti-siphon valve, and clamp.Customer asked if there was a known defect with this tubing.Received from accredo a report with malfunction from jan - june 2023, where 67 patients were affected.About injuries no major issues were reported, some patients mentioned exhibiting pah symptoms.

Manufacturer Narrative

Other text: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.D4: udi, catalog number, lot number, expiration date, g5, and h4 are unknown.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 17317074
• MDR Text Key: 319337163
• Report Number: 3012307300-2023-07170
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1