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

Catalog Number 383033

Device Problem Packaging Problem (3007)

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

Event Date 11/29/2023

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 bd intima-ii y 24gax0.75in prn/ec slm package seal integrity poor / questionable the following information was provided by the initial reporter; jingma's packaging is directly open and single-packed, which is equivalent to no seal.Samples cannot be returned, photos can be provided, green claims are required, and a complaint response letter is required.

Manufacturer Narrative

1.The customer returned photos and 5 defective samples, the sku is 383033, the batch code is 3135075, the seal of the unit package is poor, and only some areas show be sealed, and the seal is thin.Please see attachment (b)(4) for the photo.1) the adhesive coating on the top web of the unit package is checked and no abnormality is found.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 (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 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 related factors that cause the poor sealing of the unit package are: the adhesive coating on the top web and the sealing temperature, sealing time and air pressure of the packaging machine.2) on june 21, the heating rod of the sealing mold of r240 packaging machine failed, resulting the sealing temperature decreased and poor sealing of the unit package, and the defective products were not 100% removed.5.In response to this issue, training packaging operators: when the machine fails, it is necessary to sort 100% of the affected products and remove the defective products.Please see attachment (b)(4) for the training records.6.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): the returned photos and samples show the poor seal of the unit package, which may be caused by the failure of the heating rod of the sealing mold and the failure of 100% removing the defective products.In response to this issue, the plant has trained the packaging operators and will continue to monitor it.

Event Description

No additional information provided.

• 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: 18375871
• MDR Text Key: 331376444
• Report Number: 3014704491-2023-00839
• 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: 03/18/2024

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: 383033
• Device Lot Number: 3135075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1