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 383312

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

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 Description

It was reported that the nurse found a needle bent after opening needle cover of bd saf-t-intima¿ iv catheter safety system.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Correction: the bent needle indicated in the event description is not a reportable event malfunction, and this incident was over reported.

Manufacturer Narrative

Investigation summary: bd received a sample and a picture for investigation.The reported defect was confirmed in defective sample and picture received.However, based on the received sample and picture, we cannot confirm or associate the defect to manufacturing process.Currently we have adequate controls to detect cosmetic defect during loading of the material in the tray and after packaged.Based on dhr review for lot reported catalog 383312, all samples taken for visual and functional characteristics properly met the acceptance criteria.Investigation conclusion: based on investigation results to date, root cause for needle bent cannot be determined to manufacturing process.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: 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: 7443365
• MDR Text Key: 106158971
• Report Number: 9610847-2018-00113
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833122
• UDI-Public: 00382903833122
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

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
• Device Operator: Nurse
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383312
• Device Lot Number: 6302883
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/16/2018; 04/16/2018
• Supplement Dates FDA Received: 04/20/2018; 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other