MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM PICC SET 2-L: 5.5 FR X 50 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number PR-45052-HP

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: dilator damage is evidenced when introducing it into the vein.The insertion technique indicated by the literature is followed.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer provided two photos of a damaged dilator/sheath displaying signs of folding and wrinkling.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user to enlarge the puncture site with a scalpel prior to dilating skin.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: dilator damage is evidenced when introducing it into the vein.The insertion technique indicated by the literature is followed.

• Brand Name: ARROW AM PICC SET 2-L: 5.5 FR X 50 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7456857
• MDR Text Key: 106403948
• Report Number: 9680794-2018-00085
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K112896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: PR-45052-HP
• Device Lot Number: 14F17E0470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR