MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER; INTERVASCULAR CATHETER

Catalog Number	383335
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
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 nurse found blood leaking at the e-tubing site, near the prn root using the bd saf-t-intima¿ integrated safety catheter system, removable prn adapter.Found during use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported that the nurse found blood leaking at the e-tubing site, near the prn root using the bd saf-t-intima integrated safety catheter system, removable prn adapter.Found during use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: a device history report for lot number 6180743 was reviewed, no related abnormalities were found.Material number 383335 for lot 6180743 was manufactured on 07/06/2016.According to the sampling plan applied for product performance, this lot was accepted and released.Additionally both a photo and sample were provided to aid our quality engineer in their investigation.These samples displayed the reported failure mode, investigators noted that the device was subjected to leakage testing which produced a leak in the extension tubing near the adapter.Further investigation by way of microscope revealed a small puncture mark in the extension tubing.Based on the dimensions of the hole the most likely cause is that the tubing was punctured by the cannula of the device, however, this conclusion cannot be verified.This type of damage is not related to the manufacturing process, the cannula is covered with a needle cover during the fabrication of the device, to eliminate the occurrence of this type of defect.No capa was opened since this issue could not be confirmed as manufacturing related.Bd will continue to track and trend for this issue.
Event or Problem Description
It was reported that the nurse found blood leaking at the e-tubing site, near the prn root using the bd saf-t-intima¿ integrated safety catheter system, removable prn adapter.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER
• 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: 7602215
• Report Number: 9610847-2018-00185
• Device Sequence Number: 1590243
• Product Code: FOZ
• UDI-Device Identifier: 00382903833351
• UDI-Public: 00382903833351
• 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,Followup
• Report Date (Section B): 08/23/2018

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: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 383335
• Device Lot Number: 6180743
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018; 05/25/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/17/2018; 09/28/2018
• 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