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

Catalog Number	382544
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8411920
• Report Number: 1710034-2019-00281
• Device Sequence Number: 16536910
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Catalogue Number: 382544
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other