MAUDE Adverse Event Report: BD SUZHOU (MDS) UNKNOWN BD INTIMA II; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that bd intima ii needle went through catheter the following information was provided by the initial reporter: (b)(6) 2024 patient due to edema, using a closed intravenous drip needle intravenous drip, into the needle and then back out of the process of the steel needle, the steel needle pierced the cannula soft needle resulting in blood vessel puncture, the need for a second placement of the needle.

Manufacturer Narrative

If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

A complaint history check was unable to be performed since no material, lot/batch number was provided.A device history review was unable to be performed since no material, lot/batch number was provided.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.Based on the limited information received from the customer, following multiple attempts  (a-eura--srd-rm0019 rev:15(n)) could not be reviewed appropriately;  based on the customer¿s description with no failure issue identified it is difficult to deduce a defect on which they are reporting and connect it to a failure mode in the risk management documentation.The outcome described of leakage is assessed at multiple points in the rmf - s.Davidson.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.

Event Description

No additional information provided.

• Brand Name: UNKNOWN BD INTIMA II
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19130350
• MDR Text Key: 341465236
• Report Number: 3027605735-2024-01000
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1