MAUDE Adverse Event Report: BECTON DICKINSON BD¿ IV SET SN404 W/O BP Y-CONN; INTRAVASCULAR CATHETER

Catalog Number 59013833

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is greater asia.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd¿ iv set sn404 w/o bp y-conn tube was clamped and the drug was infused.The following information was provided by the initial reporter: after clamping the tube, drug was infused.

Manufacturer Narrative

Investigation: one sample was returned to sbdm, lot number is unknown.Clamping test under normal using condition: sbdm conduct clamping test under normal using condition for the complaint sample, the clamp could hold medicine and there was no drug infusion.Clamping test under high air pressure: sbdm conduct clamping test under air pressure(0.51mpa) for the complaint samples, the clamp could hold air and there was no air bubble leakage.However, sbdm found leakage in the another received complaint sample of (b)(4) which was the same complaint issue.Sbdm thus conducted further investigation about tube inner & outer diameter measurement and eccentricity of roller component for complaint sample and house sample.Tube inner & outer diameter measurement: using profile projector, sbdm measured the inner and outer diameter of both complaint sample and house sample, the diameter are within specification.Roller eccentricity test (unit: mm): using vernier caliper, sbdm measured the length from center to edge of roller for both received complaint sample (cavity no.: 11, minimum length: 8.22.Maximum length: 8.35) & house sample, conclusion was there seems to eccentricity in the roller.House sample inspection: sbdm inspected 30 pcs from potential lots 2811132, 2811152 and 2811232, no abnormality was observed.Sbdm also measured the roller clamp concentricity, all 30 roller clamps was within specifications.Device history record review: sbdm reviewed the manufacturing record for lots 2811132, 2811152 and 2811232, no abnormality was observed.Root cause: from investigations, sbdm conducted inspection of the complaint sample & house samples for leakage test under normal condition and high pressure.No leakage was observed on the received complaint sample.Sbdm also conducted further test of tube inner & outer measurement and check eccentricity of roller component.This is because even there was no leakage in this complaint sample, sbdm found leakage on some of the received sample in other case (b)(4), product: iv set an120 w/o bp.Sbdm found there was eccentricity in the roller component (the length from center to edge of roller (min: 8.21mm, max: 8.4mm & gap: 0.19mm) in the other case ((b)(4)).Sbdm then checked roller length from center to edge for 21 different lot from retention samples (total: 210ea) and the maximum gap was 0.19 and average gap was 0.09.In conclusion, sbdm assumed that when narrow location of the roller which has eccentricity and the smallest size of tube are met when roller clamp is in locked position, medicine leakage might occurred infrequently.

Event Description

It was reported that bd¿ iv set sn404 w/o bp y-conn tube was clamped and the drug was infused.The following information was provided by the initial reporter: after clamping the tube, drug was infused.

• Brand Name: BD¿ IV SET SN404 W/O BP Y-CONN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8595096
• MDR Text Key: 148429901
• Report Number: 2243072-2019-00885
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 59013833
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other