MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD EXTENSION SETS; ACCESSORIES, PUMP, INFUSION

Model Number	SET, EXTENSION, 30", M/M, 1.1ML, ASV 12/BX
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medial cadd extension sets customer noticed occlusion, even when pressing on plunger for this was checked during precheck and would not go forward.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set was returned for analysis in used condition without its original packaging.Visual inspection showed no discrepancies.Functional testing involved using the hydrostatic vessel in order to detect any discrepancies and occlusion was detected.The investigation determined that excess solvent applied in the solvent bonds during manufacture was the most probable cause of the reported issue.Production personnel were trained in order to reinforce the solvent application.Based on evidence and investigation, the complaint allegation was confirmed.
Event or Problem Description
A supplemental report is being sent for product problem was not added to list and b 1 needed update.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis MN 55442
• MDR Report Key: 9386681
• Report Number: 3012307300-2019-06528
• Device Sequence Number: 2242570
• Product Code: MRZ
• UDI-Device Identifier: 10610586020438
• UDI-Public: 10610586020438
• Combination Product (Y/N): N
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: SET, EXTENSION, 30", M/M, 1.1ML, ASV 12/BX
• Device Catalogue Number: 21-7060-24
• Device Lot Number: 3776444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 02/02/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/09/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1