MAUDE Adverse Event Report: BECTON DICKINSON BD¿ GRAVITY IV SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 388000

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that the bd¿ gravity iv set was missing its protective luer connection cap.The following information was provided by the initial reporter, translated from (b)(6): "according to the customer's report, when unpacking, the hcp found that there was no protective cap for luer connection.".

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.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 the bd¿ gravity iv set was missing its protective luer connection cap.The following information was provided by the initial reporter, translated from japanese: "according to the customer's report, when unpacking, the hcp found that there was no protective cap for luer connection.".

Manufacturer Narrative

Investigation summary one 388000 sample from lot 1020294 was received for investigation of complaint in which the customer has reported observing that the product was missing its male luer component.The sample was received in opened packaging, however no residual fluid was present in the line.Examination of the sample confirmed the customer's experience as it was noted that the male luer component was missing.Examination of the tubing found no signs of residual solvent.The details of this feedback were forwarded to the manufacturing site for further investigation.They confirmed that the cause of the missing luer component is likely to have occurred as a result human error, with the assembly operative inadvertently missing this assembly step.The missing component was then not identified during subsequent assembly and packaging processes.A review of the production records for lot 1020294 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer advocacy feedback database indicates that this is a rare occurrence, with a small number of similar reports received in the past 12 months against products from this manufacturing site.

• Brand Name: BD¿ GRAVITY IV SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12971455
• MDR Text Key: 286356780
• Report Number: 2243072-2021-02887
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 388000
• Device Lot Number: 1020294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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