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

Catalog Number 383083

Device Problem Improper Flow or Infusion (2954)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported bd intima bd intima clamp did not prevent blood backflow.The following information was provided by the initial reporter, translated from chinese to english: during the ward rounds with the physician, the head nurse found that when the infusion set was closed and the small clip of the indwelling needle was closed, the blood returned from the indwelling needle, and the blood returned through the small clip.

Manufacturer Narrative

1.The customer returned 5 actual samples, the sku is 383083, the batch code is 3171583, and all of the packages are unopened.1) the pinching function test of the pinch clamp is conducted on the samples , the pinch clamp is subjected to pressure (upper limit: 102kpa, that is, 15.3psi), and no leakage is found in the samples.2) the 800mm simulated clinical leakage test is carried out on the samples, and all the samples pass the test.2.Dhr/bhr review(lot#: 3171583): 1) this batch of products were assembled at intima ii auto line 2 in july 2023, and packaged at r240 package line in july 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 with no nonconformance, deviation or rework activities.4) the pinch clamp batches used in this batch of products are 3177015, 3177017, review the raw material inspection records, no abnormalities.3.Two retained samples of the complaint batch are taken for the pinching function test of pinch clamp and the 800mm simulated clinical leakage test, and all the samples pass the test.4.Possible causes: 1) when the extension tubing is not centered in the pinch clamp, the pinch clamp cannot be fully acted.2) improper sealing of the tube and excessive exertion of the patient may also lead to blood return after the closure of the pinch clamp.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process, the returned samples and retained samples all pass relevant tests, and there are no similar complaints from other hospitals about this batch of products, so it cannot be determined that the blood return after the closure of the pinch clamp is related to the quality of the product.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• 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: 18553437
• MDR Text Key: 333541960
• Report Number: 3014704491-2024-00023
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• 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: 02/12/2024

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: 383083
• Device Lot Number: 3171583
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1