MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4FX50CM SGL PRO PICC CT-LONGGW; PRO-PICC CT

Model Number	MR17034102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Next day after insertion it was not possible to aspirate or flush the picc.By contrast medium administration in radiology it was seen that the picc was separated in the body.The picc was removed transfemorally and via the basal vein.
Additional Manufacturer Narrative
The 4f pro picc was returned for evaluation.Visual inspection confirms the complaint.The device was returned in two pieces and appears to have ballooned and then burst approximately 9 cm from the hub.The second piece was a segment of lumen approximately 19 cm in length.Inspection of the returned pieces showed blockage in the 19cm lumen segment.A guidewire could only be inserted part way into the lumen segment.When pulled out from the segment the guidewire was coated with dried blood and other matter.The contract manufacturer conducted a review of the manufacture records for the lot number reported.There were no deviations or process changes in the manufacturing of this part number.The review indicated there were no non-conformances or authorized manufacturing variances issued for the lot involved.Nothing out of specification was found.A definitive root cause cannot be determined.It does not appear to be related to manufacturing.The report indicated that it was not possible to aspirate or flush the picc.A contributing factor may include flushing or power injecting against an occluded lumen.The instructions for use (ifu) contains the following warnings and precautions: do not flush against resistance.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.

• Brand Name: 4FX50CM SGL PRO PICC CT-LONGGW
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11188646
• Report Number: 2518902-2021-00001
• Device Sequence Number: 16781932
• Product Code: LJS
• UDI-Device Identifier: 00884908033076
• UDI-Public: 884908033076
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 06/03/2023
• Device Model Number: MR17034102
• Device Catalogue Number: MR17034102
• Device Lot Number: MPBC780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: 55 YR