MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ BAG ACCESS DEVICE; CONTAINER, I.V

Catalog Number 200250

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported, that the bd smartsite¿ bag access device experienced component separation.This is 2 of 5 events.The following information was provided by the initial reporter: 2 of our cadd patients had their tubing fall out of their 5-fu bags.The spike itself came out of the port.This is the first week we have started to really use the new style empty bag.In addition to the 2 above, one of the rn's had a "pump off" today and while removing the pump she noted how the tubing would spin.They gave me this bag so we could see it.It's inside a chemo bag on the counter.Further discussion with the nurses, and they said a patient last week noticed a little leaking from their bag.At the time they didn't think much of it.Another patient was noted to have some white "residue" when they came for their pump off.Did mention she noticed, the spikes go in the bag much easier than the older style bag.So perhaps they are coming out easier too.

Manufacturer Narrative

The manufacturing location for this product is gilero llc usa.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.H3.A device evaluation is anticipated ,but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 00338.D4: medical device expiration date: 10-jan-2025.H4: device manufacture date: 12-may-2022.H6: investigation summary: a complaint of set leaking during use was received from the customer.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.The supplier of this set was notified of the defect.Device history record results could not be obtained from the supplier.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

It was reported that the bd smartsite¿ bag access device experienced component separation.This is 2 of 5 events.The following information was provided by the initial reporter: 2 of our cadd patients had their tubing fall out of their 5-fu bags.The spike itself came out of the port.This is the first week we have started to really use the new style empty bag.In addition to the 2 above, one of the rn's had a "pump off" today and while removing the pump she noted how the tubing would spin.They gave me this bag so we could see it.It's inside a chemo bag on the counter.Further discussion with the nurses and they said a patient last week noticed a little leaking from their bag.At the time they didn't think much of it.Another patient was noted to have some white "residue" when they came for their pump off.Xxxxx did mention she noticed the spikes go in the bag much easier than the older style bag.So perhaps they are coming out easier too.

• Brand Name: BD SMARTSITE¿ BAG ACCESS DEVICE
• Type of Device: CONTAINER, I.V
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16773267
• MDR Text Key: 313643578
• Report Number: 2243072-2023-00646
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200250
• Device Lot Number: 00338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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