MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 18 G X 1.00 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383346
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
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 the safety on a 18 g x 1.00 in.Bd saf-t-intima iv catheter safety system did not activate during use.No injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one used unit was received for evaluation.This sample received with activated safety device completely.Dhr for lot number 6180745 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383346 with lot number 6180745 was manufactured on july 14, 2016.According to sampling plan applied for product performance, this lot was accepted and released.No values out of specification or problems during activation or exposed cannula were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.Investigation conclusion: after evaluate the sample received and find activated safety device completely, we cannot confirm either to associate the reported defect to the mfg.Process.Conclusion: based on evaluation this reported defect could be related with an incorrect use of the device by user.This is a way to leave exposed cannula after of finishing the puncture, the user performed the device activation since adapter sti prn, removing all the safety mechanism.Root cause description: based on investigation results to date, root cause for manufacturing process cannot be determined, however a possible cause could be the use incorrect of the device by user.

• Brand Name: 18 G X 1.00 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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: 7012134
• Report Number: 9610847-2017-00135
• Device Sequence Number: 685379
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 07/31/2020
• Device Catalogue Number: 383346
• Device Lot Number: 6180745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/18/2017
• 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