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

Catalog Number 383328

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Swelling (2091)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8290668, medical device expiration date: 2022-09-30, device manufacture date: 2018-11-30. Medical device lot #: 8334770, medical device expiration date: 2022-11-30, device manufacture date: 2019-01-03. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an infection occurred with a bd saf-t-intima¿ iv catheter safety system. The following information was provided by the initial reporter, "cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days. The patients needed antibiotics for treating the infection. " 1 of 3 complaints.

Manufacturer Narrative

H. 6. Investigation summary: a device history review was conducted for lot numbers 8290668 & 8334770. Our records show that this is the only instance of this issue occurring in either production batch. According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspections. Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility. Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that an infection occurred with a bd saf-t-intima¿ iv catheter safety system. The following information was provided by the initial reporter, "cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days. The patients needed antibiotics for treating the infection. " 1 of 3 complaints.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9311991
• Report Number: 9610847-2019-00677
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383328
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention