MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383328

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Alteration In Body Temperature (2682)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after placing a bd saf-t-intima iv catheter safety system into a patient for a subcutaneous infusion, the patient developed an area on his/her flank and back that was red and hot.The patient was treated with antibiotics and his/her hospitalization was extended by one week.

Manufacturer Narrative

Results: four unused/unopened representative samples were returned for evaluation.A visual inspection of the sample units revealed no damage or foreign matter in the cannula tip or catheter that could cause the reported defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5210764.Additionally, no issues were found in the device sterilization review.Conclusion: an absolute root cause for this incident cannot be confirmed as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5606469
• MDR Text Key: 43586473
• Report Number: 9610847-2016-00011
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 383328
• Device Lot Number: 5210764
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR