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

Catalog Number 381423

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a bd insyte¿ autoguard¿ shielded iv catheter would not advance into the patient and the iv broke under the patient's skin.The following was reported, "material no: 381423 batch no: 8253958.It was reported that the iv would not advance into the patient and the iv broke under the patient's skin.Event description per sales rep on sfdc pir states, "iv would not advance into patient.Iv broke under patients skin" (er nurse).

Event Description

It was reported that a bd insyte¿ autoguard¿ shielded iv catheter would not advance into the patient and the iv broke under the patient's skin.The following was reported: material no: 381423 batch no: 8253958.It was reported that the iv would not advance into the patient and the iv broke under the patients skin.Event description, per sales rep on sfdc pir states, "iv would not advance into patient.Iv broke under patients skin (er nurse).".

Manufacturer Narrative

Investigation summary: dhr review was performed on lot number: 8253958; the lot number was built on afa line 2 from 19sept18 thru 24sept18.Packaged on packaging line 9 from 21sept18 thru 26sept18 for a quantity of (b)(4).Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.Observations and testing could not be performed because units were not received for investigation of this incident.Indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 8400138
• MDR Text Key: 138383198
• Report Number: 1710034-2019-00266
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 381423
• Device Lot Number: 8253958
• Initial Date Manufacturer Received: 02/17/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/17/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other