MAUDE Adverse Event Report: BECTON DICKINSON BD¿ IV SET AN120 W/O BP; IV TUBING

Catalog Number 59012933

Device Problem Leak/Splash (1354)

Patient Problems Injury (2348); Chemical Exposure (2570)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.In this mdr, bd corporate headquarters in (b)(4) has been listed, (b)(4) is the actual manufacturing site.

Event Description

It was reported that the nurse was exposed to a chemo drug when a bd¿ iv set an120 w/o bp leaked during use.Injury and medical intervention.

Manufacturer Narrative

Results: investigation activities: sbdm received 1 sample from customer.It is supposed to have leakage on the iv set tube.Sbdm conducted leakage test with air and ink on the returned sample, and found out the leakage problem is on the iv set tube part.Analysis shows the likely cause is that the tube may be cut and torn by sharp tool and this may cause the leakage of iv set tube.Dhr review result: sbdm review dhr included extrusion work record(sbqi-m030-02), iv set assembly work record (sbqi-m050-01), iv set process inspection report(sbqi-q504-01) and iv set product inspection report(sbqi-q601-01), there is no issue.Root cause: sbdm checked the complaint sample received and found the tube was cut by scissors.Based on this, sbdm did a reproductibility test with scissors to replicate the defect confirmed the similar cutting shape as of the complaint sample.Two possible root causes include: 1st: the first one is that the tube may be damaged by scissors due to worker¿s mistake when he opened the wrapping of tube parts which are used for iv set tube assembly.2nd: the second one is that individual package of iv set product may be damaged by scissors when it was opened with scissors by users and it can be happened at the same tube parts.Corrective actions: had quality training on this customer complaint for iv set tube manufacturing process line workers and quality inspectors.Are strengthening incoming inspection for iv set tube components to improve product quality.Trained the workers not to open the tube wrapping with scissors ¿ completion date: dec.16th, 2017.Conclusion: based on investigation and analysis on the complaint case(leakage on tube), there are possible root causes: 1st: the first one is that the tube may be damaged by scissors due to worker¿s mistake when he opened the wrapping of tube components which are used for iv set tube assembly.2nd: the second one is that individual package of iv set product may be damaged by scissors when it was opened with scissors by users and it can be happened at the same tube parts.Conclusion: root cause: sbdm checked the complaint sample received and found the tube was cut by scissors.Based on this, sbdm did a reproductibility test with scissors to replicate the defect.It confirmed the similar cutting shape as of the complaint sample.Two possible root causes: 1st: the first one is that the tube may be damaged by scissors due to worker¿s mistake when he opened the wrapping of tube parts which are used for iv set tube assembly.2nd: the second one is that individual package of iv set product may be damaged by scissors when it was opened with scissors by users and it can be happened at the same tube parts.

• Brand Name: BD¿ IV SET AN120 W/O BP
• Type of Device: IV TUBING
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7148435
• MDR Text Key: 95840559
• Report Number: 2243072-2017-00407
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 59012933
• Device Lot Number: 2707292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention