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

Model Number 384539

Device Problems Crack (1135); Fluid/Blood Leak (1250); Difficult to Flush (1251)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Date picc placed (b)(6) 2022 @ 0930.Date of product experience (b)(6) 2022.Sku# 384539.Lot# 11410069.Describe event.Midline placed at 0930 with fluids infusing without issues until (b)(6) 2022 @1345 when prepping the neonate for lp rn noticed a yellowish color to the midline dressing and after further investigation found the dressing was wet.Ml dressing taken down to determine the cause of the leading.Ml would not flush so it was removed.After removal i flushed the line and the fluid was squirting out the side of the hub.The hub was cracked.And a new one placed any harm to patient? neonate did not receive medication that was infusing.Delay in care if so, please describe.Was a new piv placed for completion of prescribed therapy? was a new picc placed for completion of prescribed therapy? yes.Is product available for return? yes.

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 a crack in the luer that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.

Event Description

Date picc placed.(b)(6) 2022 at 0930.Date of product experience.8/12/2022.Sku# 384539.Lot# 11410069.Describe event.Midline placed at 0930 with fluids infusing without issues until 8/12/22 at 1345 when prepping the neonate for lp rn noticed a yellowish color to the midline dressing and after further investigation found the dressing was wet.Ml dressing taken down to determine the cause of the leading.Ml would not flush so it was removed.After removal i flushed the line and the fluid was squirting out the side of the hub.The hub was cracked.And a new one placed any harm to patient? neonate did not receive medication that was infusing.Delay in care ¿ if so, please describe.Was a new piv placed for completion of prescribed therapy? o was a new picc placed for completion of prescribed therapy? yes.Is product available for return? yes.

• 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: 15485138
• MDR Text Key: 301553262
• Report Number: 0001625425-2022-01098
• 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: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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: 11410069
• 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: 09/13/2022
• 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