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

Catalog Number 383078

Device Problem Break (1069)

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

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the catheter broke with a bd intima-ii 24gax0.75in prn slm npvc.The following information was provided by the initial reporter, translated from chinese to english: l yesterday.When i pulled out the needle today, i found that the entire hose was missing.Additional information obtained from follow up with customer (12/29/2023): the child was admitted to the hospital on (b)(6) 2023 due to acute tonsillitis, because the child was small, in order to avoid repeated puncture to cause pain to the child, the intravenous indwelling needle puncture was performed at about 15:50, blood was collected after puncture, and the intravenous infusion was fluent, and the tube was sealed at about 19:00, and the sealing fluid was pushed through the sealing tube, and no detachment of the indwelling needle was seen.At about 10:00 a.M.On (b)(6) 2023, while preparing for the child in preparation for an indwelling needle infusion, the indwelling needle was found to be dislodged and broken, with no hose visible.The possible hazards of needle breakage include skin infection, localized painful thrombosis, and other serious hazards that may lead to thrombus occlusion and heart failure.Nurse manager immediately gave the child line ultrasound, ct examination, the body is not found for the time being hose.

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 1 photo, no defective sample.The photo shows that the sample gauge is 24g, the catheter is broken near the small end of the catheter hub, and the catheter break surface cannot be identified.2.Dhr/bhr review(lot#: 3262327): 1) this batch of products were assembled at intima ii auto line 2 in october 2023, and packaged at r240 package line in october 2023.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: 3158222, 3142541, 3083132, 3158043).3.The retained samples of the complaint batch are taken for the catheter pull force test (the samples need to be soaked in warm water at 37 ° c for 72 hours before testing to simulate the human environment), and the test results are all within the product specifications.4.Cause analysis: 1) the catheter break was found on the second day after sealing, indicating that there were no abnormalities in the integrity check, exhaust process, puncture process, infusion process and sealing process of the catheter.2) the catheter is broken near the small end of the catheter hub.If the catheter is damaged or broken early in this part, it will cause obvious leakage, and the medicine liquid cannot be infused into the patient's body.3) the catheter and catheter hub are assembled by interference fit and 100% camera inspection after assembly to ensure that the assembly process meets the requirements.The catheter pull force data tested before outgoing of this batch of products conforms to the product specifications.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained samples, and no similar complaints have been received from other hospitals regarding this batch of products.The returned photo shows that the catheter is broken near the small end of the catheter hub, and the root cause of the catheter break cannot be confirmed as the defective sample is not received and what is happened after the sample is indwelled is unknown.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN SLM NPVC
• 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: 18681314
• MDR Text Key: 335073141
• Report Number: 3002601200-2024-00027
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383078
• Device Lot Number: 3262327
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention