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 383313

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd received 1 representative sample submitted for evaluation. The reported issue was confirmed upon testing of the sample. During internal flow testing, the sample was occluded. Further examination showed that excess medical grade silicone from our lubrication process was found within the cannula. The excess was stuck to the needle, clogging the cannula, resulting in occlusion. A device history record review showed no non-conformance's associated with this issue during the production of this batch. A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately. Corrective actions have been initiated and a manufacturing root cause has been identified. Actions have been made to address the issue. 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.

Event Description

It was reported that 30 bd saf-t-intima¿ iv catheter safety systems' needles were occluded with excess silicone. The following information was provided by the initial reporter, translated from (b)(6) to english: "the indwelling needle couldn't exhaust when it was connected with infusion set" via bd investigation: "during internal flow testing, the sample was occluded. Further examination showed that excess medical grade silicone from our lubrication process was found within the cannula. The excess was stuck to the needle, clogging the cannula, resulting in occlusion. ".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12586641
• MDR Text Key: 275244724
• Report Number: 9610847-2021-00490
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 0351255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial