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

Catalog Number 381411

Device Problems Product Quality Problem (1506); Structural Problem (2506)

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

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 neither the anesthetic team nor the experienced nurse could successfully place bd insyte-n¿ autoguard¿ shielded iv catheter in the vein.Additionally, the nurse reported that she felt the catheter was "shorter" than the "old" version of the catheters used before.The following information was provided by the initial reporter: ""do you know about any product changes with the 24ga insyte-n autoguard iv catheter? ((b)(4)) the packaging looks a little different but all the information including the reference number seems the same.One of our nurse practitioners came to me just now and said that she had trouble with the ¿newer¿ version and she feels that the actual catheter is shorter." anesthesia couldn¿t get the iv in.Called very experienced nurse practitioner who missed the vein using ultrasound because the she felt that the catheter was actually shorter than what she was used to with the ¿old¿ version of the catheter.She also felt like the site of the ¿flash port¿ on the needle had changed.On 07mar2018 (b)(6) added information from attachment email "re: [external] (b)(4) - acknowledgement and information request".Bd asked: "when the child was re-stuck was there any exposure to blood/bodily fluid? was the course of treatment changed? was there any medical intervention?" customer responded: "no exposure.The child just needed to be re-stuck several times, which was unusual for these expert providers.I was just asked if the product had changed because to the providers the product felt different using their normal technique".".

Manufacturer Narrative

H.6.Investigation summary: dhr review was performed on lot number 8330774; the lot number was built on afa line 4 from 04dec18 thru 09dec1.Packaged on packaging line 11 from 06dec18 thru 09dec18 for a quantity of 313,610 units.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.

Event Description

It was reported that the neither the anesthetic team nor the experienced nurse could successfully place bd insyte-n¿ autoguard¿ shielded iv catheter in the vein.Additionally, the nurse reported that she felt the catheter was "shorter" than the "old" version of the catheters used before.The following information was provided by the initial reporter: ""do you know about any product changes with the 24ga insyte-n autoguard iv catheter? (ps 923932) the packaging looks a little different but all the information including the reference number seems the same.One of our nurse practitioners came to me just now and said that she had trouble with the ¿newer¿ version and she feels that the actual catheter is shorter." anesthesia couldn¿t get the iv in.Called very experienced nurse practitioner who missed the vein using ultrasound because the she felt that the catheter was actually shorter than what she was used to with the ¿old¿ version of the catheter.She also felt like the site of the ¿flash port¿ on the needle had changed.(b)(6) 2018 dchu added information from attachment email "re: [external] pr 830389 - acknowledgement and information request".Bd asked: "when the child was re-stuck was there any exposure to blood/bodily fluid? wass the course of treatment changed? was there any medical intervention?" customer responded: "no exposure.The child just needed to be re-stuck several times, which was unusual for these expert providers.I was just asked if the product had changed because to the providers the product felt different using their normal technique".".

• Brand Name: BD INSYTE-N¿ 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: 8433594
• MDR Text Key: 143430219
• Report Number: 1710034-2019-00305
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814115
• UDI-Public: 30382903814115
• 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: 04/26/2019

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: 11/30/2021
• Device Catalogue Number: 381411
• Device Lot Number: 8330774
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 DA