MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Model Number IPN037301

Device Problem Material Rupture (1546)

Patient Problem Infiltration into Tissue (1931)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: picc was inserted on (b)(6) 2021, today the patient was in ct for power injection and started screaming during injection.Ct identified a burst.Psi injection flow rate was 3.Patient was reported to have a bad infiltration.Catheter was patent prior to ct per nurse.It was unknown if medical intervention was required for the infiltration.The picc was removed and the patient was planned for a tun neled ij.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 2-lumen picc for evaluation.The catheter appeared intentionally trimmed and contained obvious signs of use.Visual examination revealed the catheter body was ruptured near the juncture hub.Evidence of small kinks were observed just above and below the rupture on the catheter body.The walls of the ruptured material appeared thinned, which is damage consistent with over-pressurization causing the failure.The total length of the returned catheter body measured 15.75" which indicates at least 7" of the catheter body were intentionally trimmed and not returned per product drawing.The catheter body was ruptured from 381-386 mm from the distal (trimmed) end of the catheter.The returned catheter was functionally tested in accordance with the instructions-for-use provided with this kit.The ifu instructs the user, "flush lumen(s) to completely clear blood from catheter." both lumens were flushed using a water-filled lab inventory syringe.When the distal lumen was flushed, water leaked from the rupture in the catheter.The proximal line functioned as expected.The manufacturing and packaging facilities were contacted as part of this complaint investigation.The manufacturing facility stated that there are process controls capable of identifying and segregating this defect.Likewise, the subsequent process for this catheter assembly includes the stylet, which is not possible with a distinct catheter kink.The packaging facility stated that the catheter is free from any components or forces compressing the catheter body.Therefore, it was determined that the kinks/bends in the catheter could not occur during the manufacturing/assembly process.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "ensure patency of intended pressure injectable lumen of catheter prior to pressure injection to reduce the risk of catheter failure and/or patient complications." the customer report of a catheter rupture was confirmed by complaint investigation of the returned sample.The catheter body was ruptured adjacent to the juncture hub.Evidence of small kinks were observed directly above and below the catheter rupture, which indicates the catheter body likely became kinked which restricted flow, and has the potential to cause a rupture.The sample passed all relevant dimensional testing and a device history record review was performed with no relevant findings.Based on the condition of the sample received and feedback from manufacturing and packaging, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: picc was inserted on (b)(6); today the patient was in ct for power injection and started screaming during injection.Ct identified a burst.Psi injection flow rate was 3.Patient was reported to have a bad infiltration.Catheter was patent prior to ct per nurse.It was unknown if medical intervention was required for the infiltration.The picc was removed and the patient was planned for a tunneled ij.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Type of Device: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12022155
• MDR Text Key: 257190842
• Report Number: 9680794-2021-00288
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (y/n): N
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F21B0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 07/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Other