MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PLASTIC 'LOSS OF RESISTANCE SYRINGES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4900
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Six unopened devices from lot 3676379 were returned for evaluation.No used samples were returned.Upon visual inspection, no defects were noted.All underwent functional testing, and no leakage was observed at the luer lock.The customer's reported complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
Event or Problem Description
Information was received that a smiths medical loss of resistance syringe was defective.It was reported that there was a leakage at the luer lock and the product was not getting the resistance required.Another syringe was then used.

• Brand Name: PORTEX® PLASTIC 'LOSS OF RESISTANCE SYRINGES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8302285
• Report Number: 3012307300-2019-00546
• Device Sequence Number: 16157978
• Product Code: JKA
• UDI-Device Identifier: 20351688028065
• UDI-Public: 20351688028065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 4900
• Device Lot Number: 3676379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1