MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW(R) VPS(R) ACCESS KIT; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number ASK-04001-DU10

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when removing the peel-away sheath, the body separated.Tweezers were used to remove the rest of the peel-away sheath.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint of the sheath body was separated during removal was confirmed.The customer returned one peel away sheath.Visual examination of the returned sample revealed that the sheath body was torn in half along the score lines and was also torn at the sheath tip.Microscopic examination confirmed that both sheath halves are missing a piece of the tip.The distal end of both halves is jagged and stretched.A slight indent was also observed just above the separation on each half.Both score line tears appear typical and there is no sign of misuse.The sheath body length was measured on each half from the bottom of the tab to the start of the separation.One half measured 2.72 inches and the other 2.87 inches in length which is still consistent with the length specification per graphic (length: 2.625"- 2.875") and indicates that at the most a 0.155" piece became separated.A the device history record review did not reveal any manufacturing related issues.The probable cause of this complaint could not be determined based on the information provided and with an incomplete sample returned.No further action will be taken.

• Brand Name: ARROW(R) VPS(R) ACCESS KIT
• Type of Device: PERIPHERALLY INSERTED CATHETER PRODU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5508297
• MDR Text Key: 40604447
• Report Number: 1036844-2016-00162
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: ASK-04001-DU10
• Device Lot Number: 23F16A0298
• Other Device ID Number: 00801902111470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention