MAUDE Adverse Event Report: PFM MEDICAL, INC. JET-VAC; PROCEDURE TRAY

Model Number	M7854P
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) was associated with operator variability during the gluing process of a similar product line.This variability was attributed to new operators performing the gluing process in the month of december 2016.All lots manufactured during the suspected time frame have been evaluated.Retention samples from the m7854p, 1612-005 were visually inspected leak tested.Data showed no confirmation of the complaint.Ref 622280, ln 1612-019: no irregularities in glue observed.Ref 622281, ln 1612-015: no irregularities in glue observed.Ref 622286, ln 1612-018: no irregularities in glue observed.Ref m7001, ln 1612-017: no irregularities in glue observed.Ref m7854p, ln 1612-005: visual irregularities in the glue observed, less glue present and bubble inside of the glue (inside of the tube) observed.Ref 622287, ln 1612-006: no irregularities in glue observed.
Event or Problem Description
May be an air leak where the tube and luer lock connect.No patient injury.

• Brand Name: JET-VAC
• Common Device Name: PROCEDURE TRAY
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 8308698
• Report Number: 2032582-2017-00006
• Device Sequence Number: 19321301
• Product Code: GCB
• UDI-Device Identifier: 00813623011342
• UDI-Public: 00813623011342
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: M7854P
• Device Catalogue Number: M7854P
• Device Lot Number: 1612-005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1