MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report mw5082412 was received from the fda.In investigation has been initiated.
Event or Problem Description
Rn unable to flush white lumen.Tpa unsuccessful to clear line.New picc placed and when old picc line discontinued there was a hole in the line.
Additional Manufacturer Narrative
The returned device was forwarded to the contract manufacturer for evaluation.There was no visible damage to the luers, extensions, clamps, or hub.The lumen was trimmed at the 15 cm mark.The lumen was ruptured between the 1cm and 2cm depth markings.Upon cross sectioning the lumen in this region, red foreign material with the appearance of blood was found to be fully obstructing the smaller (white) lumen in this region.No dimensional issues with the lumen were discovered on prepared cross sections in this region.The investigation conducted showed the device was manufactured according to established processes and specifications.It met all production and quality requirements.The rupture may have been caused by excessive pressure from forcibly flushing an occluded lumen.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8270103
• Report Number: 2518902-2019-00012
• Device Sequence Number: 2056441
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019
• Report Date (Section F): 12/28/2018

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: 04/17/2021
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MLGM710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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
• Patient Weight: 3