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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that an infection occurred in the patient during use with the bd saf-t-intima¿ iv catheter safety system.There were 6 reported cases of infection, with one case utilizing antibiotic therapy treatment.The following information was provided by the initial reporter, translated from (b)(6) to english: ¿6 subcutaneous superinfections that occurred the same week with blue subcutaneous catheters including one episode that warranted antibiotic therapy.¿ "one episode that warranted antibiotic therapy.".

Event Description

It was reported that an infection occurred in the patient during use with the bd saf-t-intima¿ iv catheter safety system.There were 6 reported cases of infection, with one case utilizing antibiotic therapy treatment.The following information was provided by the initial reporter, translated from french to english: ¿6 subcutaneous superinfections that occurred the same week with blue subcutaneous catheters including one episode that warranted antibiotic therapy¿ "one episode that warranted antibiotic therapy".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/24/2020.H.6.Investigation: a device history record review was performed for provided lot number 0007673 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.After production, the product is sent for sterilization.The certificate of sterilization for lot number 0007673 was reviewed and all acceptance criteria was met prior to the release of this lot number.To aid in the investigation of this issue, one representative sample was returned for evaluation by our quality engineer team.Through inspection of the sample, no signs of foreign matter, contamination of the needle, or damages to the connections were identified; therefore, no defects were observed that could have contributed to this reported issue.Based on the investigation results, an exact cause could not be determined for this incident.

• 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 ; MX
• MDR Report Key: 10347674
• MDR Text Key: 202529650
• Report Number: 9610847-2020-00223
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 383328
• Device Lot Number: 0007673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention