MAUDE Adverse Event Report: EITAN MEDICAL LTD. AP101 - BLOOD SET WITH NON-VENTED SPIKE, 200 FILTER AND NEEDLELESS Y-SITE; ADMINISTRATION SET

Catalog Number 12006-000-0002

Device Problems Failure to Disconnect (2541); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

Combination product box is checked due to esubmitter bug.Sapphire pump administration sets aren't combination products.

Event Description

The complaint was reported by a customer from israel.Leakage issue.

Event Description

The complaint was reported by a customer from israel.Leakage issue.

• Brand Name: AP101 - BLOOD SET WITH NON-VENTED SPIKE, 200 FILTER AND NEEDLELESS Y-SITE
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: guy mlechkowich ; yad harutzim st. 29; netanya, 42505-29 ; IS 4250529
• MDR Report Key: 15355367
• MDR Text Key: 305058429
• Report Number: 3010293992-2022-00022
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: IS
• PMA/PMN Number: K141834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 12006-000-0002
• Device Lot Number: 0199.1308.21
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/05/2022
• 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: Unknown
• Patient Sequence Number: 1