MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿; INTRAVASCULAR CATHETER

Catalog Number	381033
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter had a black smear on the needle tip or catheter tip.
Additional Manufacturer Narrative
Investigation summary: dhr- the lot was built and packaged on afa line 11 from 31mar2018 through 04apr2018.All required challenge, set-up and in process samples were conducted and passed per specifications there were no qns initiated during the build of this lot.Received a 20ga unit with no packaging material.All components were present.Visual/microscopic evaluation: a black speck was observed on the catheter tubing (near the tip) of the unit received.The speck was loose (not embedded) and could be removed.Conclusion(s): the fm was identified as residual material introduced to the unit during the manufacturing process.A definite source of the particle could not be identified, it is possible to have originated from eva/k-resin that builds up on the bowls that feed up the material to the manufacturing machines.
Event or Problem Description
It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter had a black smear on the needle tip or catheter tip.

• Brand Name: ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8166314
• Report Number: 1710034-2018-00908
• Device Sequence Number: 16570612
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: 382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/11/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 381033
• Device Lot Number: 8087872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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