MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 384539

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

It is unknown if sample will get returned for evaluation or not.There were no images or videos provided for investigation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided or sample is returned in the future, a follow-up report will be submitted.It is unknown if sample will get returned for evaluation or not.

Event Description

¿line rn placing new picc line.During insertion, picc line broke off in pts arm.Stat cxr and us obtained.Attending and general surgery to bedside.¿.

Event Description

¿line rn placing new picc line.During insertion, picc line broke off in pts arm.Stat cxr and us obtained.Attending and general surgery to bedside.¿.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed breakage of the catheter at the base of the luer.The breakage site was examined under magnification and jagged remnants of the catheter were inside the luer.The luer also exhibited a hair line crack.The most probable cause for the breakage was most likely due to an event within the user environment.Possibly a tensile force was applied to the catheter that resulted in the breaking away of the catheter tubing from the luer.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to an event within the user environment, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15446552
• MDR Text Key: 306074152
• Report Number: 0001625425-2022-01094
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11424716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other