MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETI

Catalog Number ASA-25090-SB

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that this item broke and a picture was sent of the broken needle.Additional information indicates that there was patient involvement.The patient's condition was not provided.

Event Description

It was reported that this item broke and a picture was sent of the broken needle.Additional information indicates that there was patient involvement.The patient's condition was not provided.

Manufacturer Narrative

(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the injection needles with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.However, the customer did provide a photo that clearly shows an injection needle with a broke cannula.A corrective action is not required at this time.Based on the provided photos indicates unintentional user error caused or contributed to this event.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of a broken needle was confirmed based on photos provided from the customer.Visual examination of the customer provided photo clearly shows a broken cannula for an injection needle.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the injection needles with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle breaking could not be determined based upon the information provided and without a sample.

• Brand Name: SPINAL ANESTHESIA KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETI
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8843201
• MDR Text Key: 152702424
• Report Number: 1036844-2019-00885
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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 Catalogue Number: ASA-25090-SB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1