MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 382533

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The initial reporter also notified the fda on 04/2018 via medwatch (b)(4).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when a bd insyte¿ autoguard¿ bc shielded iv catheter was placed the blood control did not work, causing a leak.There was no report of exposure, serious injury or medical interventions.

Manufacturer Narrative

Investigation summary: device/batch history record review findings: dhr review was performed on the lot number 7276574.The lot number was built and packaged on afa line 11 from october 10, 2017 thru october 14, 2017.Per review of the dhr¿s it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Set-up and in-process samples (included but not limited) no septum challenge, no actuator challenge, unseated septum, actuator pushed thru septum, actuator/septum present, needle pierce thru septum, blood escape time test, and catheter/adapter water/air leak inspection were performed on various stages throughout the process, all the inspections passed per specifications.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing could not be performed because units were not received for investigation of this incident.Conclusions: the defect leakage beyond the septum; as stated as the reported code could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that when a bd insyte¿ autoguard¿ bc shielded iv catheter was placed the blood control did not work, causing a leak.There was no report of exposure, serious injury or medical interventions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7562107
• MDR Text Key: 109951256
• Report Number: 1710034-2018-00244
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 382533
• Device Lot Number: 7276574
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR