MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC

Model Number	MR17012600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Swelling (2091)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.
Event or Problem Description
The bandage was noted to be soaked.The bandage was changed and no leak was detected at that time.A short time later the bandage was soaked again and the patient's arm was swollen.The patient's heart rate had not dropped despite the increase in heart rate decreasing medication.It was then clearly visible that the infusion fluid was running out next to the puncture site.
Additional Manufacturer Narrative
The 2.6f vascu-picc was returned for evaluation and forwarded to medcomp engineering for review.Visual inspection of the device revealed a burst in the lumen near the 3cm mark.We are unable to determine the cause or factors that may have contributed to this event.
Additional Manufacturer Narrative
Visual inspection of the device revealed a burst in the lumen near the 3cm mark.A review of the manufacturing records for the possible lot numbers reported indicated the lumen was manufactured according to specification with no non-conformances or abnormalities.As the device was implanted for 13 days prior to the occurrence, it is determined the root cause is most likely not manufacturing related.A definitive root cause cannot be determined.A possible cause for a lumen rupture is infusing or flushing against resistance caused by a occlude or partially occluded lumen.Excessive pressure may damage the lumen.Device was used for treatment, not diagnosis.

• Brand Name: 2.6F X50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9660570
• Report Number: 2518902-2020-00006
• Device Sequence Number: 3422759
• Product Code: LJS
• UDI-Device Identifier: 00884908093711
• UDI-Public: 884908093711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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?: Yes
• Operator of Device: Other
• Device Model Number: MR17012600
• Device Catalogue Number: MR17012600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 01/23/2020; 01/23/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/26/2020; 04/20/2020
• 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