MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number MX5341LN

Device Problem Fluid/Blood Leak (1250)

Patient Problems Seizures (2063); Underdose (2542)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that a medex¿ small bore stopcock was in use with a patient when it was observed that there was medication leaking.The patient was assessed at 8:00 am and the nurse observed that there was a large amount of fluid under the patient's right leg on the sheets.The patient was being infused with propofol through the patient's right femoral central venous catheter (cvc).The cvc line was attached to a stopcock, which also managed continuous fentanyl and levophed combination delivery.Attachments were inspected and were found to be secure and without leaks.It was observed that the back of the stopcock bundle had propofol residue on it and was confirmed with a chlorhexidine gluconate wipe to clean the area.After the area was cleaned, it was observed that white fluid appeared in large drops.The patient had seizure activity at 6:00 am on the next day due to the incident and propofol infusion dosage was increased to treat the seizure activity.No permanent injury was reported.

Manufacturer Narrative

Four medex¿ small bore stopcocks were returned for investigation.Visual inspection revealed obvious damage/cracking of the returned device.The observed damage/cracking was consistent with the device being exposed to chemicals for a prolonged period of time.The design of the device is not intended to be impervious to all drugs and combinations of drugs.The observed damage/cracking would not have occurred during the production of the device.Additionally, the manufacturing facility performed a quality inspection of (b)(4) samples and functionally tested an addition (b)(4) devices and no issues were noted during inspection.Investigation determined that the root cause of the reported event was due to the improper use of the device.

Manufacturer Narrative

One stopcock was returned for evaluation.Visual inspection discovered there was obvious damage/cracking that occurred.The damage observed was consistent with prolonged chemical exposure and would not occur during normal production of the device.Based on the evidence, the root cause was attributed to the use of the product in a manner inconsistent with its instructions for use.There was no evidence to indicate that there was a defect due to the manufacturing of the device.

• Brand Name: MEDEX¿ SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6582892
• MDR Text Key: 75693213
• Report Number: 3012307300-2017-01089
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506771
• UDI-Public: 10351688506771
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/27/2019
• Device Catalogue Number: MX5341LN
• Device Lot Number: 3312279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR