MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383033

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

H.3.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 intima-ii¿ closed iv catheter system was involved with a serious injury.While no malfunction was observed, the device was involved with a patient receiving an x-ray scan.The scan results determined no additional medical intervention was needed.The following information was provided by the initial reporter: the family was going to prepare to give child a bath, they found that the child was biting needle and swallowed some part, see the needle indwelling needle is found to heparin cap yellow colloid is missing, the heparin cap body without loss, children with oral face no cyanosis, doctors, nurses and report immediately to the stomach head low foot high back on gag reflex processing, the processed with no vomiting.No cyanosis of lips, smooth breathing, x-ray detection results were normal, the family members were instructed to feed more milk and water to promote excretion, the family members had no objection.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 0202466.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, functional testing was performed on retention samples for this lot, the results of these show that the separation force required to separate the components was in accordance with the product specifications.Based on these observations and the event description provided our engineers were unable to associate the root cause for this event with our manufacturing process.See h10.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system was involved with a serious injury.While no malfunction was observed, the device was involved with a patient receiving an x-ray scan.The scan results determined no additional medical intervention was needed.The following information was provided by the initial reporter: the family was going to prepare to give child a bath, they found that the child was biting needle and swallowed some part, see the needle indwelling needle is found to heparin cap yellow colloid is missing, the heparin cap body without loss, children with oral face no cyanosis, doctors, nurses and report immediately to the stomach head low foot high back on gag reflex processing, the processed with no vomiting.No cyanosis of lips, smooth breathing, x-ray detection results were normal, the family members were instructed to feed more milk and water to promote excretion, the family members had no objection.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12606164
• MDR Text Key: 281279522
• Report Number: 3014704491-2021-00192
• 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: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/13/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0202466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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
• Patient Outcome(s): Required Intervention