MAUDE Adverse Event Report: 6 IN NON-DEHP MICROBORE BI-FUSE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1001
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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.
Event or Problem Description
It was reported that 6 in non-dehp microbore bi-fuse set was cracked.The following information was provided by the initial reporter: it was reported by the customer that the hub cracked while reattaching it to the patient's picc line.
Event or Problem Description
It was reported that 6 in non-dehp microbore bi-fuse set was cracked.The following information was provided by the initial reporter: it was reported by the customer that the hub cracked while reattaching it to the patient's picc line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-15.H6: investigation summary: a complaint of a sets hub cracking was received from the customer.One sample was returned for investigation.Through visual inspection the customer complaint was confirmed.Cracking at the male luer was observed.The crack went fully through the component.A device history record review could not be performed on model me1001 because a lot number was not provided by the customer.The root cause for this defect is an excess amount of stress being added to the male luer during connection, causing cracks.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: 6 IN NON-DEHP MICROBORE BI-FUSE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12089693
• Report Number: 9616066-2021-51425
• Device Sequence Number: 11953264
• Product Code: FPA
• UDI-Device Identifier: 10885403235948
• UDI-Public: 10885403235948
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 07/09/2021

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 Catalogue Number: ME1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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