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

Catalog Number 383055

Device Problems Complete Blockage (1094); Contamination (1120)

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

Event Date 08/19/2023

Event Type  malfunction  

Event Description

It was reported while using bd intima-ii¿ closed iv catheter system there was a blockage and foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) hospital.On (b)(6) 2023, the head nurse performed indwelling needle infusion treatment for the patient, and a blockage occurred in the afternoon.The nurse removed the catheter and asked the patient to press the puncture point.After pressing, the patient found a 3-4cm foreign body at the puncture point.Since the foreign body had been discarded and could not be sent back for examination, the patient hoped that the hospital would give a result of the incident.Received an update from the sales representative, and the description of the incident was updated as follows: at 20:59 on (b)(6) 2023, in the first obstetrics department of our hospital, pregnant women were admitted to the hospital due to "fetal distress? upper respiratory tract infection".On admission, the pregnant woman had a high body temperature, a rapid pulse, and a high baseline fetal heart rate.Administer rehydration therapy as directed by your doctor.At about 14:30 pm on (b)(6) 2023, when the fluid was infused, it was found that the fluid did not drip, and there was a lot of blood in the needle tube.The indwelling needle was pulled out, and the integrity of the indwelling needle was checked, and the surrounding skin was free of redness and swelling.The nurse tells the patient to press the cotton swab for 5 minutes.At around 22:35 on (b)(6), family members reported to the nurse station that after pressing, they found a foreign object about 0.5cm long at the eye of the indwelling needle.They then pulled it out and the total length was about 4cm.It was similar to a red blood thread-like foreign object and was tough and elastic.The nurse checked the needle eye and found no redness, swelling, induration, fever or other discomfort, and continued to observe the pregnant woman's reaction.

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 there was a blockage and foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) hospital.On (b)(6) 2023, the head nurse performed indwelling needle infusion treatment for the patient, and a blockage occurred in the afternoon.The nurse removed the catheter and asked the patient to press the puncture point.After pressing, the patient found a 3-4cm foreign body at the puncture point.Since the foreign body had been discarded and could not be sent back for examination, the patient hoped that the hospital would give a result of the incident.Received an update from the sales representative, and the description of the incident was updated as follows: at 20:59 on (b)(6) 2023, in the first obstetrics department of our hospital, pregnant women were admitted to the hospital due to "fetal distress? upper respiratory tract infection".On admission, the pregnant woman had a high body temperature, a rapid pulse, and a high baseline fetal heart rate.Administer rehydration therapy as directed by your doctor.At about 14:30 pm on (b)(6), when the fluid was infused, it was found that the fluid did not drip, and there was a lot of blood in the needle tube.The indwelling needle was pulled out, and the integrity of the indwelling needle was checked, and the surrounding skin was free of redness and swelling.The nurse tells the patient to press the cotton swab for 5 minutes.At around 22:35 on (b)(6), family members reported to the nurse station that after pressing, they found a foreign object about 0.5cm long at the eye of the indwelling needle.They then pulled it out and the total length was about 4cm.It was similar to a red blood thread-like foreign object and was tough and elastic.The nurse checked the needle eye and found no redness, swelling, induration, fever or other discomfort, and continued to observe the pregnant woman's reaction.

Manufacturer Narrative

The following fields have been updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 04-sep-2023.H6: investigation summary: a device history review was conducted for lot number 3108435.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 returned device was inspected and found to be free of any foreign material and fluid was able to flow through the device uninhibited.The photograph displayed a fibrous material of unknown composition.This nonconformance has been confirmed, however without the ability to analyze the foreign body our engineers were not able to determine the root cause for this event.To prevent future occurrences our engineers have issued a training notification to the relevant production personnel.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• 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: 17768782
• MDR Text Key: 324146683
• Report Number: 3014704491-2023-00563
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830558
• UDI-Public: (01)00382903830558
• 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: 09/28/2023

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: 383055
• Device Lot Number: 3108435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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