MAUDE Adverse Event Report: BECTON DICKINSON IV SET AN122 W/O PUMP T-TYPE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 59011533

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2021

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 (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.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 iv set an122 w/o pump t-type was disconnected.The following information was provided by the initial reporter: iv set tip was easily disconnected.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/22/2021.H.6.Investigation: 1 sample was returned to sbdm, lot number is unknown.Taper gage inspection of the complaint sample: sbdm inspected the received complaint sample and retention samples of the components (lot no.201208 & 210219), taper gage of adapter in the samples are in spec.Investigation under normal condition of using condition for the an122: sbdm connect the tip of complaint sample and received sample filter but, there was no leakage in the an122 sample.Investigation under high pressure of using condition for the an122: sbdm fill medicine into the spike & chamber under high pressure (0.72mpa), there was no leakage in the an122 tip.Taper gage inspection of the house samples: sbdm inspected the lot no.(lot no.2101131, 2101213 & 2101262) as of the house samples, taper gage of all adapter of house samples are in spec.Dhr review: sbdm review the manufacturing record of complaint sample (lot no.2101131, 2101213 & 2101262), there is no issue while manufacturing.Customer complaint record review: sbdm reviewed the customer complaint record of complaint sample (lot no.2101131, 2101213 & 2101262), there is no same issue of the same product (iv set an122 w/o pump t-type) from other customer.Root cause: from investigations, sbdm had inspected the complaint sample & house samples, there was no issue on adapter tip of complaint sample.Sbdm also inspected adaptor tip components (1shot = 60ea) but, all components were in spec.Sbdm review injection molding process of adapter, there was no issue too.

Event Description

It was reported that iv set an122 w/o pump t-type was disconnected.The following information was provided by the initial reporter: iv set tip was easily disconnected.

• Brand Name: IV SET AN122 W/O PUMP T-TYPE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11507153
• MDR Text Key: 268233078
• Report Number: 2243072-2021-00815
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 59011533
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1