MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II 22GAX1.00IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383064

Device Problem Break (1069)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not provided, therefore, xx was used as a place holder.D.4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that bd intima-ii 22gax1.00in prn slm npvc catheter broke.The following information was provided by the initial reporter, translated from chinese to english: the patient was treated with an infusion using a closed iv indwelling needle on (b)(6) 2024, when he saw blood return and then backed out of the needle to feed the hose, which did not feed smoothly, rupturing a blood vessel and causing a subcutaneous bruise.The front end of the hose was seen to bifurcate upon removal of the indwelling needle, and a new closed-ended indwelling needle was replaced with a smooth feed to complete the infusion treatment.

Manufacturer Narrative

1.Dhr/bhr review (lot#: 2291981): 1) this batch of products were assembled at intima ii auto line 3 in november 2022, and packaged at cfs package line in november 2022.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.2.No defective samples and photos have been received, and the status of the front end of the catheter bifurcated cannot be identified.3.The retained sample of this batch is examined under the microscope, and no abnormality is found of catheter tipping.Penetration force test is carried out on the sample, the needle tip force, catheter tip force and catheter drag force all meet the product specifications.4.According to the complaint, the front end of the catheter bifurcation is found after the puncture, not before the puncture, and the defect may be related to the quality of the product, and may also be related to the patient's skin, vessel condition and puncture method.5.According to the experience of previous market visits, it is recommended to insert the indwelling needle at 15° to 30°, and then lower the angle to 5° to 10° to continue feeding.Ensure that the needle tip does not touch the blood vessel wall, and do not reinsert the needle core into the catheter to avoid the needle tip injuring the catheter and blood vessel.6.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.As the defective sample has not been received for further inspection and analysis, and the usage of the sample is unknown, the root cause of the bifurcation of the front end of the catheter cannot be confirmed, and the plant will continue to track and trend for this issue.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II 22GAX1.00IN 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: 18704699
• MDR Text Key: 336400780
• Report Number: 3002601200-2024-00036
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830640
• UDI-Public: (01)00382903830640
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: Other
• Device Catalogue Number: 383064
• Device Lot Number: 2291981
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/23/2024
• 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