MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 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	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: investigation summary: no sample or photo was returned for evaluation.Dhr is to be completed.Once complete a supplemental will be filed.Investigation conclusion: without defective sample or photo for us is very difficult to determinate the root of cause, since according with provided information by customer the damage in the catheter could be related when the device is incorrectly activated, its makes that the memory of material (tubing) will cause a ¿sling shot¿ sending the needle to his original position resulting in damage in the catheter.We were not able to associate the reported defect to the mfg.Process this is the first reported complaint with this catalog.Root cause description: we could not find the exactly root cause of the issue since no sample or photo was returned for evaluation.
Event or Problem Description
It was reported that the catheter on a bd saf-t-intima¿ iv catheter safety system leaks during insertion and when removed.No injury or medical intervention.
Additional Manufacturer Narrative
Investigation / dhr: dhr for lot number 6243986 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383346 with lot number 6243986 was manufactured on september 27, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During this batch 360 samples were taken by qa tech, for performed leak test between connections the product in final assembly, no leaks were found.Additionally all functional test meets specification criteria requested during manufacturing.All relevant information during the dhr review shown that meet all established manufacturing criteria.

• Brand Name: 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: 7156831
• Report Number: 9610847-2017-00209
• Device Sequence Number: 19194408
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383346
• Device Lot Number: 6243986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/11/2018
• 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