MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II 24GAX0.75IN PRN SLM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problem Break (1069)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii 24gax0.75in prn slm catheter was defective/damaged.The following information was provided by the initial reporter translated from chinese to english: a nurse in the emergency department gave a 2-year-old child an injection that was normal to check before it was prescribed, and the child kept crying, so the needle went in and then withdrew part of it, and when she checked the integrity of the catheter after the ooze was over, she found a visible hair rub on the front of the catheter.I zoomed in with my mobile phone to take a picture and found that the front end of the catheter was uneven.I was afraid that there was residual catheter in the patient's body and wanted to check the integrity of the catheter.Google translation.The nurse in the emergency department gave a 2-year-old child an injection.The check before the injection was normal.The child kept crying, so after the needle went in, it partially pulled out.After the leakage was over, when the integrity of the catheter was checked, the front end of the catheter was found.There are obvious scratches.I used my mobile phone to zoom in and take pictures, and found that the front end of the catheter was uneven.I was afraid that there was residual catheter in the patient's body, so i wanted to check whether the catheter was intact.No further details provided.

Event Description

No additional information provided.

Manufacturer Narrative

1 the customer returned 1 defective sample.1 the sample is examined under microscope there are two damages in the head of the catheter, one of which is small, the bevel part is notched and poorly formed, and the other damage is large, with obvious scratch on one side without missing parts.2 dhr bhr review lot 3325174.1 this batch of products were assembled at intima ii auto line 3 in january 2024, and packaged at cfs package line in january 2024 work order quantity was (b)(4) ea 2 review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3 review the production records with no nonconformance, deviation or rework activities.4 review incoming inspection records of catheter, no abnormalities material number b5171aaal, batch number 3177665, 3177666, 3158044, 3117920, 3094808, 3142540.3 check the retained samples of this batch, and no abnormality is found in the catheter head.4 cause analysis: 1 the notch and poor forming in the bevel part of the catheter are mainly related to the dirty tipping die after the tipping die is used for a long time, there will be residual debris on the inside of the tipping die, which will cause the catheter head to be poorly formed or show a notch from july 2023, the plant has increased the cleaning frequency of the tipping die from 1 time 8 hours to 1 time 4 hours to reduce the occurrence of the defects.2 obvious scratch in the catheter head are clearly related to abnormal puncture 5 no similar complaints have been received from other hospitals regarding this batch of products.Conclusion: no abnormality is found on process and retained samples, and no similar complaints have been received from other hospitals regarding this batch of products there are two damages in the catheter head of the returned sample one damage may be related to the dirty tipping die, and the plant has increased the cleaning frequency of the tipping die to reduce the occurrence of such defects the other damage may be related to abnormal puncture.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN SLM
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19126486
• MDR Text Key: 341256569
• Report Number: 3002601200-2024-00138
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: (01)00382903830282
• 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: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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: 383028
• Device Lot Number: 3325174
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1