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

Catalog Number CS-24301-E

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It is reported that a user facility randomly took out one product from the batch #(71f17g1978) of cvc to culture the tip of the catheter.On (b)(6), the bacterial department reported the result was staphylococcal positive 1+.

Manufacturer Narrative

Qn#(b)(4).The customer supplied five photos and a video for evaluation.The photos and the video show different angles of an unopened cvc set.The packaging appears to be damaged in certain areas but the lidstock seal appears to be intact.A device history record review was performed on the catheter and no manufacturing issues were identified.The customer returned a representative sample which was then forwarded to the manufacturing facility for evaluation.The sample was evaluated for seal area quality.The product lidstock/tray seal was found to be in good order with no issues identified (no holes, compromised seal, foreign material, creases or other defects).Based on the investigation performed, no issues were found with the returned representative sample from a sterile barrier point of view.No issue was determined which could cause contamination of the manufactured/packaged products.

Event Description

It is reported that a user facility randomly took out one product from the batch #(71f17g1978) of cvc to culture the tip of the catheter.On april 18, the bacterial department reported the result was staphylococcal positive 1+.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7491307
• MDR Text Key: 107601824
• Report Number: 3006425876-2018-00284
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F17G1978
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1