MAUDE Adverse Event Report: SMITHS MEDICAL SAF-T HOLDER DEVICE; BLOOD COLLECTION SET

Catalog Number 96000S

Device Problem Fracture (1260)

Patient Problem Occlusion (1984)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that during use of the listed device it broke at luer leaving a plastic piece inside the picc line.Broken piece was unable to be removed from line; therefore a new picc line was placed by interventional radiology.No permanent injury resulted from this event.

Manufacturer Narrative

One used blood collection holder was returned for inspection.Visual inspection of the returned sample confirmed that the luer area of the holder was damaged.This component is a supplied item; therefore smiths medical reviewed its receiving incoming inspection log, and purchasing specifications-regarding potential material change.No issues or changes were observed in either documentation that relates to this issue.Two-hundred random units were removed from the packaging line and visually and functionally tested.All samples were found acceptable.No luer fitting or breakage issues were discovered.The reported product problem was confirmed; the luer of the blood collection holder was found damaged.Through testing, the root cause could not be definitely determined.A potential root cause may be related to a supplier issue.It may be possible that the material was received damaged from the supplier.A supplier notification was generated and provided to the component supplier.In addition, smiths medical held a meeting with its production team to raise awareness of the issue.

• Brand Name: SAF-T HOLDER DEVICE
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL, INC.,; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5135944
• MDR Text Key: 27770465
• Report Number: 2183502-2015-00737
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 96000S
• Device Lot Number: 3022740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other