MAUDE Adverse Event Report: CAREFUSION T-CONN W/LUER SLIP ADPT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20051E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that t-conn w/luer slip adpt tubing was damaged.The following information was provided by the initial reporter: tubing is severed at the edge of pouch with complete package.
Event or Problem Description
It was reported that t-conn w/luer slip adpt tubing was damaged.The following information was provided by the initial reporter: tubing is severed at the edge of pouch with complete package.
Additional Manufacturer Narrative
Corrected information: d4.Lot# : 20016794.Investigation: one 20051e sample from lot 20016794 was received for investigation inside the sealed packaging3.A visual inspection of the sample confirmed the customer's experience as a section of the tubing was found to be sliced.Examination of the packaging also noted the tubing had protruded out of the seal of the packaging.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the damage is consistent with the tubing being caught in the heat seal of the packaging machine.If the set is not placed in the packaging nest correctly, the seal around the edge of the packaging can be compromised by the tubing protruding out of the packaging.The tubing would then be caught in the packaging heat seal, causing the damaged and split tubing.This is a manual process and is likely to have been caused by human error.A review of the production records for lot 20016794 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 20051e product in the past 12 months.

• Brand Name: T-CONN W/LUER SLIP ADPT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10198142
• Report Number: 9616066-2020-01944
• Device Sequence Number: 14014811
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: 07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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 Expiration Date: 01/21/2023
• Device Model Number: 20051E
• Device Catalogue Number: 20051E
• Device Lot Number: 20016794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other