MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC W/MST

Model Number	MD170126024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
A nurse reported an issue with a vascu-picc tls pediatric 2.6fx50cm dl mst kit.It was reported that after indwell of the device, it was noticed the catheter ballooned in two locations, causing leakage.One balloon on the catheter was internal and one was external.This resulted in a leak and positive infection culture.The patient then had a cvc placed, and then a new picc line was placed.The patient was reported as stable post event.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection confirms the complaint as the device shows a rupture in the lumen.Under magnification it appears the lumen had ballooned prior to bursting.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the devices were manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.A root cause cannot be determined but is not likely manufacture related.The most likely scenario is the lumen was subjected to excessive force such as flushing or infusing against resistance possibly due to a thrombosis or a kink in the lumen.The instructions for use (ifu) include infusion equipment and bolus injection parameters that should be followed.Small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Common catheter complications include catheter occlusion and thrombosis.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Do not flush against resistance.If the lumen will neither aspirate or flush, and it is determined that the catheter is occluded with blood, follow your institutional declotting procedure.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC W/MST
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 15504499
• Report Number: 2518902-2022-00053
• Device Sequence Number: 12734457
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 884908147230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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 Expiration Date: 04/30/2022
• Device Model Number: MD170126024S
• Device Catalogue Number: MD170126024S
• Device Lot Number: MQBD360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 1 YR
• Patient Sex: Female