MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)

Model Number 384516

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Tissue Breakdown (2681)

Event Date 01/19/2022

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

During a dressing change, liquid was noted under it, a leak in the picc line was observed.The baby did not receive all of the prescribed parenteral nutrition and developed a sore under the soaked dressing.Concerns of increased risk of infection since it is an entry route for microorganisms.The catheter was removed and the baby having to undergo a new procedure and the associated pain.

Event Description

During a dressing change, liquid was noted under it, a leak in the picc line was observed.The baby did not receive all of the prescribed parenteral nutrition and developed a sore under the soaked dressing.Concerns of increased risk of infection since it is an entry route for microorganisms.The catheter was removed and the baby having to undergo a new procedure and the associated pain.

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.

Manufacturer Narrative

According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

Event Description

During a dressing change, liquid was noted under it, a leak in the picc line was observed.The baby did not receive all of the prescribed parenteral nutrition and developed a sore under the soaked dressing.Concerns of increased risk of infection since it is an entry route for microorganisms.The catheter was removed and the baby having to undergo a new procedure and the associated pain.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
• 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: 13480203
• MDR Text Key: 289485977
• Report Number: 0001625425-2022-00943
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384516
• Device Catalogue Number: 384516
• Device Lot Number: 11385286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/01/2022; 02/01/2022
• Supplement Dates FDA Received: 03/09/2022; 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other