MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN; INTRAVASCUALR CATHETER

Catalog Number 329487

Device Problem Failure to Deliver (2338)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported while using bd intima-ii¿ prn y adapter 22 ga 1 in the medication could not be delivered.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: a new pen needle of 5mm was clog.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd intima-ii¿ prn y adapter 22 ga 1 in the medication could not be delivered.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: a new pen needle of 5mm was clog.

Manufacturer Narrative

The following fields have been updated due to additional information: h.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD INTIMA-II¿ PRN Y ADAPTER 22 GA 1 IN
• Type of Device: INTRAVASCUALR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17873692
• MDR Text Key: 324976154
• Report Number: 3014704491-2023-00625
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 06943174101705
• UDI-Public: (01)06943174101705
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 329487
• Device Lot Number: 1282505
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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