MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383312

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

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2020

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 two bd saf-t-intima safety systems with removable prns 24 ga 0.75 in were involved with serious injury in the form of infection.Two patients experienced infection during use of the device from the user facility.It has not been specified whether any medical intervention was sought or received as a result of the infections.The following information was provided by the initial reporter: got feedback from the head nurse.During the infusion of indwelling needles in the ward in (b)(6) 2020, she found that 3 indwelling needles, (lot 9086671(2)), appeared puncture site infection in the last 10 days.The customer suspected that the indwelling needles were related to the indwelling needles, and hoped that our company would pay attention to it.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9086671 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, three picture samples were returned for evaluation by our quality engineer team; however, the product described in this incident was not observed in the picture samples and therefore, was unavailable for evaluation or testing.The picture samples did appear to display the reported complaint of infection.After the saf-t-intima product is manufactured, it is sent of sterilization.The sterilization records for this lot number were reviewed and all criteria was met.At this time, a manufacturing related cause cannot be identified for this incident.See h.10.

Event Description

It was reported that two bd saf-t-intima¿ safety systems with removable prns 24 ga 0.75 in were involved with serious injury in the form of infection.Two patients experienced infection during use of the device from the user facility.It has not been specified whether any medical intervention was sought or received as a result of the infections.The following information was provided by the initial reporter: got feedback from the head nurse.During the infusion of indwelling needles in the ward in (b)(6) 2020, she found that 3 indwelling needles, (lot 9086671(2)), appeared puncture site infection in the last 10 days.The customer suspected that the indwelling needles were related to the indwelling needles, and hoped that our company would pay attention to it.

• Brand Name: BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN
• 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: 10237332
• MDR Text Key: 199719236
• Report Number: 9610847-2020-00200
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 9086671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other