MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-04301-KR

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device product is not intended for sale in the us.Similar product (510k#) sold in the us.

Event Description

The customer reports the ars (syringe) was found leaking during use.A new kit was used.

Manufacturer Narrative

(b)(4).The customer returned one arrow-raulerson syringe (ars) and lidstock for evaluation.Visual examination of the returned syringe did not reveal any defects or anomalies.A vacuum leak test was performed on the ars.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 within 1 cc of its original position, therefore, the sample passed the functional inspection.The ars was used to draw water out of a lab measuring cup.No issues were identified.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user, "do not aspirate with guidewire in place or air will enter syringe." the customer reported issue of the ars leaking could not be confirmed during the sample investigation.Visual and functional inspections were performed and no issues were identified.A device history record review was performed and no relevant findings were identified.As no problem was found with the returned sample no further action will be taken.

Event Description

The customer reports the ars (syringe) was found leaking during use.A new kit was used.

• Brand Name: ARROW CVC KIT: 16 GA X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7502275
• MDR Text Key: 107987459
• Report Number: 3006425876-2018-00290
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: ASK-04301-KR
• Device Lot Number: 71F17D1868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1