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

Catalog Number 383078

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone #: unknown.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 after the fourth day, the catheter was removed and was discovered that there was a wound associated with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient finished infusion at 13:20 on (b)(6) 26, 2019.After pulling out the intravenous indwelling needle (the fourth day of indwelling catheter), found that there was a 3*1 cm 2 wound associated with medical device at the fixed place of the indwelling needle handle.Local disinfection was immediately given, and removed the shedding skin, and cleaned with brine swabs.After dry care, alginate gel dressing + wound dressing was used for dressing change.

Manufacturer Narrative

Investigation summary: no defective picture or sample were returned.Checked the batch record of this lot, no abnormality found on in-process inspection, fg inspection record.Checked the retained samples 30pcs.No abnormal conditions were found at the indwelling needle handle.When the iv indwelling needle was removed for the patient on the fourth day after catherization, it was found that there was a 3*1cm2 medical-equipment-related injury at the fixed place of the indwelling needle handle.This indicates that the indwelling needle is normal during the first 4 days of use.No same compliant was received from the complaint lot.No defective sample returned and no abnormal found on process.The product was in normal use for the first 4 days, and the use status was unknown afterwards.There was a 3*1cm2 medical device related injury at the fixed place of the retained needle handle, which was unrelated to the factory.

Event Description

It was reported that after the fourth day, the catheter was removed and was discovered that there was a wound associated with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: the patient finished infusion at 13:20 on (b)(6) 2019.After pulling out the intravenous indwelling needle (the fourth day of indwelling catheter), found that there was a 3*1 cm 2 wound associated with medical device at the fixed place of the indwelling needle handle.Local disinfection was immediately given, and removed the shedding skin, and cleaned with brine swabs.After dry care, alginate gel dressing + wound dressing was used for dressing change.

• 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
• MDR Report Key: 8965770
• MDR Text Key: 156644778
• Report Number: 3006948883-2019-00731
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/04/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8079076
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other