MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® VENIPUNCTURE NEEDLE-PRO® SAFETY DEVICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 4140

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that a jelco® venipuncture needle-pro® safety device did not have a hollowed groove in the orange adaptor, which prevented the needle from locking into the safety device.The issue was observed after use on a patient.No patient or clinician injury was reported.See mfr: 3012307300-2016-00612.

Manufacturer Narrative

Two jelco venipuncture needle-pro safety device was returned for evaluation.It could not be determined which device was associated with the reported event; therefore, the evaluation of both devices was used for the medwatch.Visual inspection found that the needle channel was not completely formed and molded.The presence of plastic material would not allow needle engagement during application.The evidence shows that the root cause of the incomplete molding is attributed to a supplier injection molding process issue.

• Brand Name: JELCO® VENIPUNCTURE NEEDLE-PRO® SAFETY DEVICE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6198241
• MDR Text Key: 63083905
• Report Number: 3012307300-2016-00614
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2021
• Device Catalogue Number: 4140
• Device Lot Number: 3293925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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