MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 14 FR X 15 CM ANTI; CATHETER, HEMODIALYSIS, NON-I

Catalog Number CDC-22142-X1A

Device Problem Product Quality Problem (1506)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

While disposing of sharps in expired trays, the user was stuck by an unsheathed needle in a catheterization kit.It was reported "no medical intervention needed, just needed a band aid".No patient involvement.

Event Description

While disposing of sharps in expired trays, the user was stuck by an unsheathed needle in a catheterization kit.It was reported "no medical intervention needed, just needed a band aid".No patient involvement.

Manufacturer Narrative

Qn# (b)(4).The customer did not return a complaint sample; however, they supplied two photos showing a needle/luer slip syringe assembly within a kit.The protective needle guard had fallen off the assembly; however, the cause of this cannot be officially determined without the actual complaint sample returned for analysis.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "do not use if package is damaged".The report that the needle guard came off the assembly was confirmed through examination of the customer supplied images.The images show that the needle guard came off the needle/luer-slip syringe assembly; however, the actual complaint sample was not returned for analysis.A device history record review was performed with no evidence to suggest a manufacturing related cause.The probable cause of the observed defect cannot be officially confirmed as visual analysis cannot be performed to verify if the observed failure mode is packaging or manufacturing related.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 14 FR X 15 CM ANTI
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11508926
• MDR Text Key: 240635267
• Report Number: 1036844-2021-00050
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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: 01/31/2021
• Device Catalogue Number: CDC-22142-X1A
• Device Lot Number: 23F19H0349
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1