MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383012

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported, a device history review was conducted for lot number 0322662.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd intima ii¿ iv catheter prn adapter packaging seal was damaged and air leaked into it.The following information was provided by the initial reporter, translated from chinese: "the patient was seen at 08:00 on (b)(6) 2022 due to "bronchopneumonitis", and was prepared for infusion treatment at 09:00.When the disposable indwelling needle was opened, air leakage was found in the package, and a new indwelling needle was immediately replaced.No further problems were found, and infusion was successfully completed.".

Manufacturer Narrative

H6: investigation summary; a device history review was conducted for lot number 0322662.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

Event Description

It was reported that the bd intima ii¿ iv catheter prn adapter packaging seal was damaged and air leaked into it.The following information was provided by the initial reporter, translated from chinese: "the patient was seen at 08:00 on (b)(6) 2022 due to "bronchopneumonitis", and was prepared for infusion treatment at 09:00.When the disposable indwelling needle was opened, air leakage was found in the package, and a new indwelling needle was immediately replaced.No further problems were found, and infusion was successfully completed.".

• Brand Name: BD INTIMA II¿ IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15421887
• MDR Text Key: 300770658
• Report Number: 3014704491-2022-00410
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/25/2023
• Device Catalogue Number: 383012
• Device Lot Number: 0322662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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