MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10; INTRAVASCULAR CATHETER

Catalog Number	383550
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd nexiva closed iv catheter system single port with maxzero¿ needleless connector 24 ga 0.56 in (0.7 x 14 mm).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 the bd nexiva closed iv catheter system single port with maxzero¿ needleless connector 24 ga 0.56 in (0.7 x 14 mm) experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 383550; batch no: 7300656.Per customer email: i received a call this afternoon from a user facility with a concern regarding material 383550.The nurse states that when they were using the butterfly on the patient there was a yellow plastic material by the wings of the product.Not knowing what they plastic material was, they removed the product from the patient and have set it aside to have it reviewed by bd.
Additional Manufacturer Narrative
Investigation: a device history review was conducted for lot number 7300656.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally our engineers reviewed the device submitted but was unable to observe any evidence of the reported foreign material in the unit provided.Unfortunately without the ability to observe the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.
Event or Problem Description
It was reported that the bd nexiva closed iv catheter system ¿ single port with maxzero¿ needleless connector 24 ga 0.56 in (0.7 x 14 mm) experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 383550.Batch no: 7300656.Per customer email: i received a call this afternoon from a user facility with a concern regarding material 383550.The nurse states that when they were using the butterfly on the patient there was a yellow plastic material by the wings of the product.Not knowing what they plastic material was, they removed the product from the patient and have set it aside to have it reviewed by bd.

• Brand Name: SEE H.10
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8680193
• Report Number: 9610847-2019-00407
• Device Sequence Number: 2232304
• Product Code: FOZ
• UDI-Device Identifier: 30382903835509
• UDI-Public: 30382903835509
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383550
• Device Lot Number: 7300656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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