MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELOADED; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-35552-VPS

Device Problems Wrinkled (2614); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed on a female patient.During insertion the peel-away sheath was pulling back from the introducer.As a result, they completed the procedure by using a picc seldinger conversion set.There was no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint of sheath pulled back from the dilator at insertion was confirmed.The customer returned one peel-away sheath/ dilator assembly.The assembly appeared typical except for the damaged sheath tip.Microscopic examination revealed that the sheath tip edge is pushed back about 1.0mm and is accordion to 2.0mm.Microscopic examination of the dilator revealed that the tip was also damaged and the body was bend approximately 3 cm from the tip.The tip was pushed back slightly along half of the tip edge.The sheath measured 2.76" in length which meets specification per sheath graphic (length: 2.625 -2.875").The sheath tip inside diameter (id) could not be accurately measured due to the tip damage.The dilator protruded through the sheath tip 0.0866" which meets the specification of 0.625- 1.125" in the assembly graphic.The dilator outside diameter was specified at 0.071- 0.075" per extrusion graphic.The inside diameter of the tip was specified at 0.020-0.022" per dilator graphic.The dilator outside diameter measured 0.0715" which meets the od specification and the other remarks: inside tip diameter could not be measured due to the tip damage.However, a 0.018" pin gage was passed through the dilator without resistance.The ifu for this product provided insertion techniques for the sheath/ dilator assembly.The customer did not report their insertion technique.A device history record review was performed and did not reveal any manufacturing related issues.Based on the reported information, the time of discovery and the condition of the sample operational context caused or contributed to this event.No further action will be taken.

• Brand Name: PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELOADED
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• 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: 5623217
• MDR Text Key: 44121840
• Report Number: 1036844-2016-00239
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121941
• 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: 04/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: CDC-35552-VPS
• Device Lot Number: 23T15M0083
• Other Device ID Number: 00801902074881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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