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

Catalog Number 383078

Device Problem Leak/Splash (1354)

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm npvc adapter/connector/defective/damaged.The following information was provided by the initial reporter: the nurse used the product "closed intravenous needle" to puncture the child's vein, checked the quality of the product's appearance before the operation, and saw no obvious abnormality, and gave the puncture operation, and found that the blood overflowed from the heparin cap when the saline was used to seal the tube after the puncture was successful, and gave the needle to be clamped closed immediately, and examined the location of the blood seepage, and found that there was a crack in the anterior end of the connection of the heparin cap.After fully communicating with the family, he replaced the indwelling needle to complete the operation.

Manufacturer Narrative

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

Manufacturer Narrative

1.Based on available information (blood overflow from the prn; there is a crack in the anterior end of the connection of the prn; the prn is not damaged), which is understood to mean that the pp connector of the defective sample is cracked.2.The customer returned 1 photo, no defective sample.Blood leakage from the connection between the prn and the pp connector can be identified from the photo.However, the crack of the pp connector cannot be identified from the photo.3.Dhr/bhr review(lot#3353152): 1)this batch of products were assembled at intima ii auto line 2 in january 2024, and packaged at r240 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)the pp connector batches used in this batch of products are 3331968, 3331969, 3331970, review the raw material inspection records, no abnormalities.4.The retained sample of this batch is taken for 45psi leakage test, no leakage is found, and no abnormality is found on the pp connector.Please see attachment for the test report.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found in the process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.Blood leakage from the connection between the prn and the pp connector can be identified from the returned photo.However, the crack of the pp connector cannot be identified from the photo, and the defective sample has not been returned, so the root cause of cracking of the pp connector cannot be determined.

Event Description

No additional information provided.

• 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: 19198337
• MDR Text Key: 341681584
• Report Number: 3014704491-2024-00055
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: (01)00382903830787
• 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: 05/07/2024

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: 383078
• Device Lot Number: 3353152
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1