MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-45854-HP

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is reported that the patient had no known allergies.

Event Description

It was reported that: patient was going to operating theatres for a cardiac procedure.The patient received im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting red skin over trunk, arms and legs, extremely low bp and heart rate.Adrenaline was administered and symptoms resolved.Plain triple lumen cvc was then inserted, and procedure could continue.

Manufacturer Narrative

(b)(4).The customer returned one 4-lumen cvc and lidstock for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination of the catheter did not reveal any defects or anomalies.The catheter coating appeared typical with no discoloration.The total length of the catheter body measured to be 216 mm , which is within specifications of 207-227 mm per product drawing.The returned catheter was flushed using a lab inventory syringe to ensure no blockages were present.The catheter flushed as expected.The distal end of the catheter was occluded and each extension line was pressurized using a water-filled lab inventory syringe.No leaks were detected.Additional testing of the catheter coating could not be performed as the catheter was inserted into the patient.Once the catheter is inserted, the coating begins releasing into the bloodstream.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit states, "use of arrowg+ard blue plus antimicrobial catheter technology is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." the customer indicated that the patient had no known allergies.The customer report of an allergic reaction could not be confirmed by complaint investigation of the returned catheter.The catheter passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.The customer stated that the patient had no known allergies and no issues were found with the returned catheter; therefore, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: patient was going to operating theatres for a cardiac procedure.The patient received im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting red skin over trunk, arms and legs, extremely low bp and heart rate.Adrenaline was administered and symptoms resolved.Plain triple lumen cvc was then inserted, and procedure could continue.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10062589
• MDR Text Key: 191159097
• Report Number: 3006425876-2020-00431
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Catalogue Number: CS-45854-HP
• Device Lot Number: 71F19F0453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR