MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383012

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Phlebitis (2004)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0238626, medical device expiration date: 2023-09-23, device manufacture date: 2020-08-25; medical device lot #: 0357724, medical device expiration date: 2023-09-23, device manufacture date: 2020-08-25; medical device lot #: 0019787, medical device expiration date: 2023-09-23, device manufacture date: 2020-08-25; medical device lot #: 1111465, medical device expiration date: 2023-09-23, device manufacture date: 2020-08-25.

Event Description

It was reported that after using 16 bd intima-ii¿ closed iv catheter systems medical intervention was performed due to phlebitis.An infusion of oxytocin and magnesium sulfate was maintained by mircropump.The needle was removed and thrombosis was found according to a b-ultrasound.The following information was provided by the initial reporter: "the infusion of oxytocin and magnesium sulfate was maintained by micropump.The needle was removed immediately after phlebitis was found later, and thrombosis was found according to b-ultrasound.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/27/2021.H.6.Investigation: a device history review was conducted for lot number 0357724.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A photograph was submitted displaying the irritation experienced by the patients, but did not display the affected device.The physical samples also were submitted to aid in our investigation into this issue.Functional testing of the returned units was not able to detect any burrs or other abnormalities that could have resulted in the observe adverse event.Additionally this lot was treated and received a certificate of conformance for sterility.Based on these observations our engineers were not able to determine the root cause for this event.

Event Description

It was reported that after using 16 bd intima-ii¿ closed iv catheter systems medical intervention was performed due to phlebitis.An infusion of oxytocin and magnesium sulfate was maintained by mircropump.The needle was removed and thrombosis was found according to a b-ultrasound.The following information was provided by the initial reporter: " the infusion of oxytocin and magnesium sulfate was maintained by micropump.The needle was removed immediately after phlebitis was found later, and thrombosis was found according to b-ultrasound.".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13283193
• MDR Text Key: 287349178
• Report Number: 3014704491-2021-00455
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383012
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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