MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383318

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

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 after use a bd saf-t-intima¿ iv catheter safety system malfunctioned as "needle safety failure occurred" there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, 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 Description

It was reported that after use a bd saf-t-intima¿ iv catheter safety system malfunctioned as "needle safety failure occurred" there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: a sample was submitted for the purpose of our investigation.The reported failure mode could not be observed by our investigative team.Both samples had a functional safety device, however one device did have a bent needle upon receipt.The device history report for lot number 7241750 was reviewed, no related abnormalities were found.Material number 383318 for lot 7241750 was manufactured on 09/17/2017.According to the sampling plan applied for product performance, this lot was accepted and released.Additionally during the manufacture of this device quality assurance technicians conducted pull force testing to verify machinery was operating within specified parameters.Based on the samples the root cause cannot be finalized because the initial failure mode could neither be observed nor replicated.Additionally the failure mode of needle bent, although observed, is not related with the manufacturing process.No known complications lead to either defect.We could not confirm the issue at our customer facility with the provided information.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.No corrective action required at the failure.Process fmea rm4797 was reviewed and there are proper controls in place to detect product malfunctions.

Event Description

It was reported that after use a bd saf-t-intima¿ iv catheter safety system malfunctioned as "needle safety failure occurred" there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM
• Type of Device: 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: 7515070
• MDR Text Key: 108493736
• Report Number: 9610847-2018-00138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 383318
• Device Lot Number: 7241750
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other