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

Catalog Number 381434

Device Problems Product Quality Problem (1506); Defective Device (2588)

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

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter tubing was defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.381434 batch no.8278790.(1/8).It was reported the catheters were kinking and perforating.Customer claims catheters stiffness is different since we changed our packaging.Says its softer and does not work well.Customer says they are experienced nurses and have been using iagbc for 2 years so it's not a user issue.These are the comments from their staff.(b)(6) 2019 rn - my issues are decreased flexibility of new caths.They are kinking in person's veins.It is taking multiple iv starts.They are very frustrating.There has been increased incidence that the iv cath is being perforated with an attempt and having this happen increases the risk that a tip could break off in a patients vein, leaving the hospital prone to litigation.Note: it is a patient safety issue.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter tubing was defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.381434 batch no.8278790 (1/8) it was reported the catheters were kinking and perforating.Customer claims catheters stiffness is different since we changed our packaging.Says its softer and does not work well.Customer says they are experienced nurses and have been using iagbc for 2 years so it's not a user issue.These are the comments from their staff.2019-01-25 rn - my issues are decreased flexibility of new caths.They are kinking in person's veins.It is taking multiple iv starts.They are very frustrating.There has been increased incidence that the iv cath is being perforated with an attempt and having this happen increases the risk that a tip could break off in a patients vein, leaving the hospital prone to litigation.Note: it is a patient safety issue.

Manufacturer Narrative

H.6.Investigation: during dhr review all required challenge samples and testing was performed per specification in accordance with the setup and in-process sampling plans.There were no indications of the defect as it was noted that there were reject findings throughout the build of this lot that would impact upon the quality of the catheter product.Photo: one photo provided for observation of this incident.Photo (__k__w_ 002) showed three 20ga bd iag iv catheter packages: 1 opened package was from lot 5149996 / exp.2018-05, 1 opened package from an unknown lot number and one package (not confirmed if opened or not) from lot 8278790.The photo also shown two catheter/adapter assemblies.Samples: received 2 used 20ga bd insyte autoguard catheter units which consisted of the catheter/adapter assemblies intact, the remainder of the units was returned for evaluation.Unit #1 was within the opened package seen in the photo that had an unknown lot (portion of top web/label) was torn away from the package.The package has hand written on it ¿new¿.Unit #2 was within the opened package seen in the photo from lot 5149996.The package had hand writing on it ¿old").Visual/microscopic examination (test method: n/a): photo: the photo provided for this incident did not present sufficient evidence to identify the defect of catheter kink / bent, as stated in the pir.The catheter/adapter assemblies in the provided photo did not reveal any visible anomalies or damage.Samples: unit #1 (new packaging): there were no anomalies or damage to the catheter tubing (i.E.Holes, splits, kinks or wrinkles).There were no anomalies or damage to the adapter (i.E.Cracks / grooves, smashed, mis-molds or inside or outside thread damage).Unit #2 (old packaging): although there was a very slight curve to the tubing observed, which was insignificant, it was confirmed that there were no anomalies or damage to the catheter tubing (i.E.Holes, splits, kinks or wrinkles).There were no anomalies or damage to the adapter (i.E.Cracks / grooves, smashed, mis-molds or inside or outside thread damage).The photo and units provided for this incident did not present sufficient evidence to identify or confirm the alleged defect therefore a definite root cause was not be established.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 8480364
• MDR Text Key: 141022762
• Report Number: 1710034-2019-00372
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 381434
• Device Lot Number: 8278790
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other