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

Catalog Number 382534

Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)

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

Event Date 05/22/2018

Event Type  malfunction  

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.

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed. There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: device/batch history record review: dhrs are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable. Findings: although a dhr review it required for this mdr complaint, review was not conducted because a lot number was not provided for this incident. Sap (qn) database review: no. Reason: this database tracks any issue during production that would affect product quality. Findings: subject code was an s1 severity ranking. Review was not conducted for this mdr- level a investigation, because a lot number was not provided for this incident. Analysis of peura and/or fmea conducted by qe: the peura (end user risk analysis) rm5835 rev 12 version j was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Visual analysis: observations and testing: observations and testing could not be performed because units were not received for investigation of this incident. Investigation samples(s) meet manufacturing specifications: unknown; units were not received for observation and testing. Investigation conclusion: root cause is indeterminate. Comment: units not provided for investigation of the incident stated in the pir.

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed. There was no report of injury or medical interventions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7602862
• MDR Text Key: 111697711
• Report Number: 1710034-2018-00288
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: 30382903825340
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382534
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/14/2018 Patient Sequence Number: 1