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

Catalog Number 383028

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use with bd intima¿-ii iv catheter the catheter was kinked and caused blood vessel to rupture.Patient was re-punctured and device replaced.The following information was provided by the initial reporter, translated from chinese to english: at 15:00 on (b)(6) 2023, when the oxytocin group was infused intravenously with an indwelling needle, the hose of the punctured indwelling needle was bent, causing the blood vessel to rupture, and the re-puncture caused pain to the patient.

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.  the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that during use with bd intima¿-ii iv catheter the catheter was kinked and caused blood vessel to rupture.Patient was re-punctured and device replaced.The following information was provided by the initial reporter, translated from chinese to english: at 15:00 on (b)(6) 2023, when the oxytocin group was infused intravenously with an indwelling needle, the hose of the punctured indwelling needle was bent, causing the blood vessel to rupture, and the re-puncture caused pain to the patient.

• Brand Name: BD INTIMA¿-II IV CATHETER
• 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 ; 8448235433
• MDR Report Key: 17276157
• MDR Text Key: 318975306
• Report Number: 3014704491-2023-00318
• 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: 07/10/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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