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

Catalog Number 383005

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.Examination of the product involved may provide clarification as to the cause for the reported failure.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode due to no samples or photos being returned.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system was used on the patient after a cesarean section, and while "the first day of use was good", a rash appeared around the puncture site the second day."anti-allergic treatment with "dexamethasone injection" and "calcium gluconate"" was used on the affected area, along with removal of the catheter system, and the rash "gradually disappeared without itching" afterward.As reported by the customer, translated from (b)(6) to english, "after cesarean section, pregnant patient used intima ii for infusion.The first day of use was good.On the second day puncture site appeared rash, with itching.Anti-allergic treatment with "dexamethasone injection" and "calcium gluconate" and removal of intima ii, the rash gradually disappeared without itching.(b)(4).

• 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 ; 8015652341
• MDR Report Key: 8388070
• MDR Text Key: 137790852
• Report Number: 3006948883-2019-00155
• Device Sequence Number: 0
• Product Code: FOZ
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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