MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

Catalog Number 384221

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

There was no lot number available; therefore, a review of the lot number could not be conducted.There were no samples returned for review; however, an image was provided.Based on the image provided, breakage is confirmed just below the inverted triangle of the extension set.The image does not provide a clear view of the breakage site to verify a straight or jagged edge.A straight edge would indicate the catheter might have been cut and a jagged edge would be indicative of tensile force being applied to the catheter.Without the sample to review, a definite root cause and corrective action cannot be established.If the sample is returned for evaluation, a follow-up report will be submitted.

Event Description

¿bedside rn went to bedside @ 2200 to do hourly picc line check.She has visualized the line previously at 2000 and 2100 and it was wnl.Ar 2200, she found the picc line lying in the bed beside the baby.The line snapped at the side of the heart closest to the baby.The remaining portion of the line was still secured to the baby¿s arm by picc dressing.¿ per the photo-(b)(4):the injection cap was placed directly on the hub of picc no lot# provided.

Manufacturer Narrative

There was no lot number available; therefore, a review of the lot number could not be conducted.One sample was returned for evaluation.Breakage was observed just under the inverted triangle of the silicone extension set.The breakage was examined under magnification and it was noted the edges were slightly jagged which is indicative of a tensile force being applied to the catheter.Possible causes for the breakage at the inverted triangle of the extension set could be related to patient movement or securement issues.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 7508426
• MDR Text Key: 108370411
• Report Number: 1625425-2018-00046
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention