MAUDE Adverse Event Report: MEDCOMP 1.9FX50CM SGL LMN V-P BASC KIT; VASCU-PICC

Model Number	MR17011101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one 1.9f picc from customer for evaluation.Complaint reported that the lumen burst near the hub.Visual examination of the device confirmed the complaint.The device was forwarded to medcomp engineering for review.Returned device was inspected by medcomp engineering and found the id, od, and wall were within tolerance near the hole in the lumen.Visual inspection revealed the catheter is wavy in the area of the hole between the hub and 2cm depth mark.Under magnification, the hole in the lumen is smooth and appears to have burst rather than cut by something such as the stylet.While a definitive root cause cannot be determined, it is determined the root cause is not manufacturing based.Risk assessment documentation reviewed, failure mode is covered, no new risks were identified.
Event or Problem Description
After the catheter was inserted the guidewire was removed and the catheter salinized.It was immediately noticed that the catheter lumen had ruptured near the suture wings.Catheter was removed and replaced with another.No adverse clinical consequences to the patient were reported.

• Brand Name: 1.9FX50CM SGL LMN V-P BASC KIT
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9083520
• Report Number: 2518902-2019-00059
• Device Sequence Number: 2568552
• Product Code: LJS
• UDI-Device Identifier: 00884908032659
• UDI-Public: 884908032659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K120980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: MR17011101
• Device Catalogue Number: MR17011101
• Device Lot Number: MLLJ150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/18/2019
• 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