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

Catalog Number 382534

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device lot #: unknown.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with needle retraction failure.It was stated ¿the needle is difficult to retract.Plastic cannula difficult to advance.There was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: device/batch history record review: 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) (b)(4) 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 relationship of device to the reported incident: indeterminate - units not provided for investigation of the incident stated in the pir.Comment: each dispenser is accompanied by an ifu (instructions for use) insert which explains use and cautions.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with needle retraction failure.It was stated ¿the needle is difficult to retract.Plastic cannula difficult to advance.There was no report of injury or further medical intervention.

• 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: 7563326
• MDR Text Key: 109950813
• Report Number: 1710034-2018-00291
• 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: 06/01/2018
• 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
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other