MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER, PERCUTANEOUS

Catalog Number ES-04301

Device Problems Air Leak (1008); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: during insertion of the catheter, the doctor found the ars (syringe) was not tightly connected and air entered.The doctor replaced the device and completed the treatment.

Manufacturer Narrative

(b)(4).The customer returned an arrow-raulerson syringe (ars) and spring wire guide (swg) for evaluation.Visual examination of both devices did not reveal any defects or anomalies.The handle of the ars was broken to examine the valve inside.The valve consists of two bi-lateral valve pieces and a spacer.Microscopic examination was performed and no damage was observed to either of the valve pieces.A vacuum leak test was performed on the ars per inspection procedure.With the plunger body at the bottom of the syringe, the tip of the ars was occluded and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released and it snapped back to its original position.The ars passes the test if the plunger returns to its original position; therefore, the sample passed the functional inspection.A lab inventory introducer needle was attached to the returned syringe and water was aspirated into the ars.Water filled the syringe with no air bubbles entering.A device history record review was performed on the ars and no relevant manufacturing issues were identified.The report that the ars leaked could not be confirmed through functional testing of the returned sample.The ars sample passed the vacuum leak test and functional testing with the returned introducer needle and water.No leaks were found during testing and the syringe was able to aspirate.No problem was found on the returned sample.

Event Description

The customer reports: during insertion of the catheter, the doctor found the ars (syringe) was not tightly connected and air entered.The doctor replaced the device and completed the treatment.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7483073
• MDR Text Key: 107361805
• Report Number: 3006425876-2018-00278
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F17A1232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1