MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN.; INTERVASCULAR CATHETER

Catalog Number	383335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 saf-t-intima iv catheter safety system with prn adapter 20 g x 1.00 in.Experienced breakage during use.The following information was provided by the initial reporter: the extension tubing was broken and leaked when unclamped.
Additional Manufacturer Narrative
Investigation: a device history review was conducted for lot number 7026678.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 after investigating the damaged sample our engineers were able to determine that it was caused by the tip of the needle.Based on this observation they were able to determine that this damage was incurred during the use of the device.Given our current production method the tip of the needle never has the opportunity to create this type of non-conformance.Unfortunately based on our observations, 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 saf-t-intima iv catheter safety system with prn adapter 20 g x 1.00 in.Experienced breakage during use.The following information was provided by the initial reporter: the extension tubing was broken and leaked when unclamped.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN.
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8496795
• Report Number: 9610847-2019-00284
• Device Sequence Number: 13855934
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: 30382903833352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 01/31/2021
• Device Catalogue Number: 383335
• Device Lot Number: 7026678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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