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

Model Number	MRVSP26001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bedside nurse performing assessment and noted bleeding from dressing.Upon further investigation noted leaking from catheter under dressing.Catheter immediately removed for patient safety.
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.
Additional Manufacturer Narrative
The complained device was not returned for evaluation and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the catheter lot number reported.The device history record review showed nothing out of specification, no authorized manufacture variance, non-conformance report, or reworks related to the reported failure mode.The lot was manufactured according to specifications.The device is received from an external supplier and is visually and functionally inspected.Samples are pull tested on all hub junctions which includes the lumen to hub junction.The minimal acceptable result for this junction is 1.124 lbs.All samples passed for the catheter lot indicated in this incident.All results were above 2.0 lbs.The instructions for use (ifu) contains the following warnings and precautions: small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.Examine catheter lumen and extension(s) before and after each infusion for damage.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.
Additional Manufacturer Narrative
The device involved was returned and the complaint was reopened.Visual inspection of the returned device revealed a great deal of adhesive on the hub and extension tubing.A burst in the lumen was noted just below the hub.Blood was noted in the lumen from approximately 1.5cm to 5cm from the hub.A small balloon was also noted in the lumen approximately 4cm from the hub.Photographs taken under magnification were reviewed by medcomp engineering.No apparent manufacture issues were noted.The device history record review showed nothing out of specification, with no authorized manufacture variance, non-conformance report, or reworks related to the reported failure mode.The lot was manufactured according to specifications.The device subassembly is received from an external supplier and is visually and functionally inspected.At the completion of the final manufacture processes, the catheters are 100% leak tested.Catheter lumens with damage, such as holes, ruptures, tears and/or small pinholes will be detected during this test.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) contains the following warnings, precautions, and statements: *small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*do not use sharp instruments near the extension lines or catheter lumen.*do not use scissors to remove dressing.*examine catheter lumen and extension(s) before and after each infusion for damage.*do not flush against resistance.*if resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.If the lumen will neither aspirate nor flush, and it has been determined that the catheter is occluded with blood, follow institutional declotting procedure.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC TLS
• 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: 16520579
• Report Number: 2518902-2023-00020
• Device Sequence Number: 6515411
• Product Code: LJS
• UDI-Device Identifier: 00884908163391
• UDI-Public: 00884908163391
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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: 06/30/2024
• Device Model Number: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MMJM980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023; 03/03/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/17/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 9 KG