MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL POWER PAC TRAY LL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4471-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that while a smiths medical implantable port was in use, no reflux occurred.Xray has shown a left-sided, dysfunctional port with a small defect at the proximal end of the catheter.Leakage occurred to surrounding tissue where catheter runs under the clavicle.As a result, the device was then removed.
Additional Manufacturer Narrative
Device evaluation : one pac (port a cath) was received for investigation with the catheter attached to the port.Immediate visual inspection detected a crack in the catheter.To further investigate the issue, a review of the manufacturing process was conducted and was considered adequate and correct.Production personnel performs a 100% visual inspection during manufacturing to ensure that the catheter is not bent, kinked, or damaged.They also test patency by using a connector in the end of the catheter, to verify no leaks are present and that the catheter is not split.Additionally, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Based on the evaluation, the complaint allegation was confirmed.Though no problem source was identified, it was noted the most probable source of the event was damage to the device after the product left a smiths facility.
Additional Manufacturer Narrative
Additional information updated fields: lot number and expiration date and manufacture date.

• Brand Name: SMITHS MEDICAL POWER PAC TRAY LL
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9037967
• Report Number: 3012307300-2019-04902
• Device Sequence Number: 14013576
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: 10610586032745
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-4471-24
• Device Lot Number: 3703701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 11/17/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/18/2019; 12/11/2019
• 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: Required Intervention