MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH SFTY KIT: 19G CTH, 17GX8CM NDL; ANESTHESIA CONDUCTION KIT

Catalog Number AB-19608-KS

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation has not been submitted at this time.The manufacturer will continue to monitor and trend related events.

Event Description

During patient use 3 catheters were used before finding one that flow would properly come out.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the stimucath catheter with no relevant findings.The customer reported the catheter would not flow properly and the distal tip was crimped.The customer returned one stimucath catheter, one snaplock adapter, and lidstock ((b)(4)).The returned components were received connected together.The returned components were visually examined with and without magnification.The snaplock adapter appears typical with no defects or anomalies observed.Visual examination of the returned catheter reveals the distal tip is bent.There appears to be no damage to the exposed coils or the extrusion at the distal end ((b)(4)).No other defects or anomalies were observed.A functional flow test was performed on the returned sample.The returned stimucath catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed.The snaplock adapter was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.Flow was confirmed coming from the distal end of the catheter; however, the flow was intermittent and red other remarks: biological material was coming from the distal end.The ifu for this product, b-02060-101c: rev.03, was reviewed as a part of this complaint investigation.The ifu for this product warns the user, "do not advance catheter more than 5 cm." also, "do not force catheter if resistance is encountered." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the stimucath catheter distal tip being crimped and not flowing properly was confirmed based upon the sample received.The returned catheter's distal tip was bent and the flow was intermittent with red biological material was coming from the distal end during functional flow testing.The ifu for this product warns the user not advance catheter more than 5cm as well as do not force catheter if resistance is encountered.A device history record review was performed on the stimucath catheter with no relevant findings.Therefore, based upon the condition of the sample received and the time of discovery, operational context caused or contributed to this event.

Event Description

During patient use 3 catheters were used before finding one that flow would properly come out.The patient's condition was reported as fine.

• Brand Name: STIMUCATH SFTY KIT: 19G CTH, 17GX8CM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5937649
• MDR Text Key: 54273458
• Report Number: 1036844-2016-00479
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: AB-19608-KS
• Device Lot Number: 23F16B0880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1