MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383005

Device Problems Leak/Splash (1354); Unsealed Device Packaging (1444)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced leakage.The following information was provided by the initial reporter: the prn was checked before the operation, and it was found that the outer package was damaged and air leakage was found.The prn without air leakage was immediately replaced with a new device.

Manufacturer Narrative

The following information has been corrected: b5: describe event or problem: it was reported that the bd intima-ii¿ closed iv catheter system experienced damaged unit packaging with a breach in sterility.The following information was provided by the initial reporter: the prn was checked before the operation, and it was found that the outer package was damaged and air leakage was found.The prn without air leakage was immediately replaced with a new device.F11: imdrf annex a code: a020503.H6: investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1111432.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.The patient's indwelling needle on day 3 indicated that there was no abnormality in the initial use of the product.No defective picture or sample returned, the broken and bent state of the interface of the prn of the indwelling needle cannot be confirmed.Due to the unclear description, whether the package damage and air leakage refers to the package of the indwelling needle or the replacement of prn can not be confirmed.Dhr review of the indwelling needle (lot#1111432): the complaint gauge is 18g, assembly at auto line 4 in (b)(6) 2021,packaging at r240 packing machine in (b)(6) 2021, lot quantity is 186k; reviewed the in process test and outgoing test report for this lot product, all test results met the product specifications, no abnormality found; reviewed the production record and machine troubleshooting records for this lot product, and no abnormality, deviation or rework activities were found; the prn lot number for this product is lot #1078627/1113824, reviewed the incoming inspection result, no abnormality found for it.Checked the package and prn interface of the retained samples of this batch of indwelling needle.No abnormality was found.No abnormality found on process.As no defective sample was returned, and the usage during the period is unknown, the root cause of the broken and bent interface of the prn of the indwelling needle cannot be determined.In addition, it is not clear whether the package damage and air leakage refers to the package of indwelling needle or the replacement of prn, and its root cause cannot be determined.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced damaged unit packaging with a breach in sterility.The following information was provided by the initial reporter: the prn was checked before the operation, and it was found that the outer package was damaged and air leakage was found.The prn without air leakage was immediately replaced with a new device.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13081282
• MDR Text Key: 285751823
• Report Number: 3014704491-2021-00386
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383005
• Device Lot Number: 1111432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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