MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problem Material Discolored (1170)

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

Event Date 09/02/2023

Event Type  malfunction  

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¿ closed iv catheter system the end cap was discolored.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinse to english: when the nurse punctured the child, she took out the indwelling needle from the package and found that the indwelling needle had no needle guard cap and the heparin cap was white in color.Replacing the indwelling needle for puncture caused patients to question the quality of the hospital's products.

Event Description

It was reported while using bd intima-ii¿ closed iv catheter system the end cap was discolored.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinse to english: when the nurse punctured the child, she took out the indwelling needle from the package and found that the indwelling needle had no needle guard cap and the heparin cap was white in color.Replacing the indwelling needle for puncture caused patients to question the quality of the hospital's products.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-sep-2023.H6: investigation summary.A device history review was conducted for lot number 3052817.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.Additionally, a sample and a photograph were returned to aid in our investigation.The unit was returned in an opened packaging unit and displayed the reported whitened heparin cap and the missing needle shield.This event has been confirmed.A review of the retained samples for this lot was also conducted.All retained samples displayed a needle shield and a heparin cap in normal condition.Needle shields can become loosened in transit and subsequently lost upon opening the device.Unfortunately, the root cause for this complaint cannot be identified, as the presence of the needle shield could not be verified due to the opened packaging unit.Meanwhile the whitened heparin cap is the result of advanced aging and is caused by storage or transportation of the device in a highly oxidative of hot environment.The retained analysis suggests this aging occurred after the device left the manufacturing facility.H3 other text : see h10.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17805279
• MDR Text Key: 324146743
• Report Number: 3014704491-2023-00590
• 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: 09/29/2023

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: 383028
• Device Lot Number: 3052817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/24/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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