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 Problems Abscess (1690); Inflammation (1932); Necrosis (1971)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the patient presented inflammation while using bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: between august 2019 and now, 13 patients have been registered at the geriatrics unit in several different units for having presented inflammations (some of which were significant) at the puncture site of the subcutaneous device, sometimes associated with a local infectious problem, despite compliance with the institutional hygiene protocol in force (use of an alcoholic antiseptic on the skin before setting up the infusion, changing the device after a maximum of 96 hours) by personnel experienced in this type of procedure.Additional information added on the 7th of august.For the other cases mentioned, as these were retrospectively reported cases, the batches were not listed at the time of the adverse event.As stated in my report, i do not have a mechanism to address you.Concerning the consequences on patients : 1 patient who presented a collection of poor evolution at the sc puncture site on the abdomen: incision of the abscess that shows necrosis + antibiotic therapy + wicking.

Event Description

It was reported that the patient presented inflammation while using bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: between (b)(6) 2019 and now, 13 patients have been registered at the geriatrics unit in several different units for having presented inflammations (some of which were significant) at the puncture site of the subcutaneous device, sometimes associated with a local infectious problem, despite compliance with the institutional hygiene protocol in force (use of an alcoholic antiseptic on the skin before setting up the infusion, changing the device after a maximum of 96 hours) by personnel experienced in this type of procedure.Additional information added on the (b)(6).For the other cases mentioned, as these were retrospectively reported cases, the batches were not listed at the time of the adverse event.As stated in my report, i do not have a mechanism to address you.Concerning the consequences on patients : 1 patient who presented a collection of poor evolution at the sc puncture site on the abdomen: incision of the abscess that shows necrosis + antibiotic therapy + wicking.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was performed for provided lot number 0036796 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one picture sample was provided for evaluation by our quality engineer team.The picture sample revealed skin irritation, however, it did not show the saf-t-intima product.The sterilization records were reviewed for this lot number, and all requirements were within specification.At this time, a cause related to the manufacturing process cannot be determined for this incident.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.

• 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: 10463648
• MDR Text Key: 204693551
• Report Number: 9610847-2020-00265
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 383328
• Device Lot Number: 0036796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention