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

Model Number 383312

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

It was reported that the needle disconnected while using bd saf-t-intima¿ iv catheter safety system.There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, when the nurse used the "closed-tip automatic retractable indwelling needle" to puncture a patient, the needle was disconnected from the yellow retaining wing when the needle core was removed after successful puncture.The product was replaced with a new one and used normally.".

Manufacturer Narrative

Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.No capa - based on an evaluation of severity and frequency, no corrective action was performed to since this issue could not be confirmed as manufacturing related.

Manufacturer Narrative

Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.No capa - based on an evaluation of severity and frequency, no corrective action was performed to since this issue could not be confirmed as manufacturing related.

Event Description

It was reported that the needle disconnected while using bd saf-t-intima¿ iv catheter safety system.There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, when the nurse used the "closed-tip automatic retractable indwelling needle" to puncture a patient, the needle was disconnected from the yellow retaining wing when the needle core was removed after successful puncture.The product was replaced with a new one and used normally.".

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13122484
• MDR Text Key: 285765331
• Report Number: 9610847-2021-00628
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 9281580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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