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

Catalog Number 382544

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had foreign matter.No serious injury or medical intervention was reported.Verbatim: "before using the catheter the staff member observed that there was some extra vialon material at the end of the catheter.They then abandoned the cannulation and used another cannula.".

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had foreign matter.No serious injury or medical intervention was reported.Verbatim: "before using the catheter the staff member observed that there was some extra vialon material at the end of the catheter.They then abandoned the cannulation and used another cannula.".

Manufacturer Narrative

Investigation summary: the dhr review was not performed since the lot number related to this investigation was unknown.Received one 18ga iag bc catheter-adapter assembly with no packaging material.Visual examination: ¿the needle had speared through the catheter tubing.¿a v-shaped cut left by the needle tip was observed near the catheter tip.¿the remainder cut off of the catheter tubing (non-foreign) was attached to the catheter tip.Conclusion(s): the defect found on the catheter tip was caused by the manufacturing process (tipping) of the product.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators to ensure process changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.

• 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: 8411920
• MDR Text Key: 138651394
• Report Number: 1710034-2019-00281
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382544
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other