MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFESHIELD EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	12648
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.The investigation is not complete.
Event or Problem Description
The event involved a customer allegation stating that upon opening of the original packaging, a bit of plastic debris was observed to be in the tubing.There was no medication being used with the product.No additional information was reported.There was no patient involvement.
Additional Manufacturer Narrative
Initially, the customer indicated that the device would be returned for investigation.Multiple attempts were made to retrieve the device; however, the device was not received for investigation.Subsequently, testing could not be performed.A batch record review of the reported lot referenced in the event revealed no discrepancies that may have contributed to a complaint of this nature.All quality assurance testing performed during manufacturing was found to be acceptable.The quality assurance review of the specified lot indicates the product meets specifications.

• Brand Name: LIFESHIELD EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia, ; CS
• MDR Report Key: 7886606
• Report Number: 9615050-2018-00052
• Device Sequence Number: 16189464
• Product Code: FPA
• UDI-Device Identifier: 10887787005469
• UDI-Public: 10887787005469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 12648
• Device Catalogue Number: 12648
• Device Lot Number: 86583
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1