MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383403

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Thrombus (2101)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that on (b)(6) 2016, a bd intima-ii closed iv catheter system was inserted into a patient for infusion therapy after surgery.The iv remained in the patient until (b)(64) 2016, at which time a new iv was placed.On (b)(6) 2016, the patient complained of pain at the iv insertion site so a nurse used a steel cannula for the patient's infusions instead.On (b)(6)2016, the patient claimed that the vein in his hand had become hard.There was no obvious swelling but a thrombus was identified by a color doppler ultrasound.The nurse applied topical magnesium sulfate and alcohol to the patient's iv insertion site to help relieve pain.The patient also received "chinese traditional medicine" via iv infusion to dissolve the thrombus.The patient recovered on (b)(6) 2016.

Manufacturer Narrative

Correction: the initial mdr reported this incident as both an adverse event and product problem.A correction is being submitted to report the incident as an adverse event only.

Manufacturer Narrative

Results: although it was initially reported that a sample would be available for evaluation, a sample was not returned.A review of the device history record and the device sterility record revealed no irregularities during the manufacture of the reported lot # 5229059.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5481321
• MDR Text Key: 39744631
• Report Number: 3006948883-2016-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 383403
• Device Lot Number: 5229059
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: 53 YR