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

Catalog Number 383033

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 24gax0.75in prn/ec slm package seal integrity was poor / questionable the following information was provided by the initial reporter: jingma's single packaging is not firmly adhered, which is equivalent to not being sealed; samples cannot be returned, photos can be provided, green claims are required, a complaint response letter is required, and an acceptance letter is not required.

Manufacturer Narrative

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

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 2 photos, no defective sample.The photos show: the sku is 383033, the batch code is 3135075, and the unit package has no sealing trace.2.Dhr/bhr review(lot#3135075): 1) this batch of products were assembled at intima ii auto line 4 in june 2023, and packaged at r240 package machine in june 2023.Work order quantity was 198,000 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 and equipment maintenance records, it is found that the heating rod of the sealing mold of r240 packaging machine was faulty in the morning shift on june 21.Please see attachment (b)(4) for the maintenance records.3.Check the retained samples of the complained batch, no unit package is found to be poorly sealed.Please see attachment (b)(4) for the inspection report.4.Cause analysis: 1) the plant has received the same batch of samples with the same defect from the same hospital (complaint no.: (b)(4)).Through inspection and analysis, it was determined that the heating rod of the sealing mold of r240 packaging machin failed on june 21, the sealing temperature decreased, and the affected defective products were not 100% removed, resulting in the poor sealing of the unit package.2)in response to this incident, the plant has trained the packaging operators: when the machine fails, 100% of the affected products should be sorted and 100% of the defective products should be removed.Please see attachment (b)(4) for the training records.Conclusion(s): the returned photos show that there is no seal trace of the unit package, which is caused by the failure of the heating rod of the sealing mold, the sealing temperature is reduced, and the affected defective products are not 100% removed.In response to this incident, the plant has trained the packaging operators and will continue to monitor.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN/EC 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: 18470324
• MDR Text Key: 332991902
• Report Number: 3014704491-2024-00006
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: (01)00382903830336
• 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: 03/24/2024

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: 383033
• Device Lot Number: 3135075
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 03/24/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1