MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW L-L LOSS OF RESISTANCE SYRINGE COMPONENT; SYRINGE, PISTON

Catalog Number LR-05503

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product usage when the alleged issue was discovered is unknown.It is unknown if the device sample is available for evaluation.

Event Description

The customer alleges that lor syringe is sticking and does not move smoothly when in use.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned for analysis.No lot number was provided.An attempt was made to retrieve a lot number from sales history data.However, no record could be found of this hospital purchasing the reported product code.A device history record review could not be performed.A corrective action is not required at this time as the potential cause of difficulty sliding the plunger of the lor syringe could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The potential cause of difficulty sliding the syringe plunger could not be determined based upon the information provided and without a sample.

Event Description

The customer alleges that lor syringe is sticking and does not move smoothly when in use.No patient injury or harm reported.

• Brand Name: ARROW L-L LOSS OF RESISTANCE SYRINGE COMPONENT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5225681
• MDR Text Key: 31256164
• Report Number: 1036844-2015-00528
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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 Catalogue Number: LR-05503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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