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

Catalog Number 383028

Device Problem Material Rupture (1546)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

D.The lot number 20153142208 provided has not been found and cannot be verified.D.4.Medical device expiration date: unknown.E1.Address information was not provided, therefore, xx was used as a place holder.H.4.Device manufacture date: unknown.H3.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 bd intima-ii 24gax0.75in prn slm npvc ruptured.The following information was provided by the initial reporter, translated from chinese to english: the ct enhancement scan was not completed as expected when the indwelling needle ruptured, requiring a multi-departmental re-coordination to reassure the patient and re-complete the previous tasks.

Manufacturer Narrative

1.From the photo and video returned, it is identified that the extension tubing of the indwelling needle has expanded and ruptured.2.Sku#383028 is an intima ii product (pvc extension tubing).The intended use for the bd intima ii product is the intravascular administration of fluids.The maximum pressure the product can withstand is 45 psi (300kpa), and this product has never been declared to be used for high-pressure injection.3.If the instantaneous pressure through the product exceeds 45psi, the pvc extension tubing has the defect probability of expansion and rupture.Conclusion(s): the complained defects is related to the use end, and have nothing to do with product quality.

Event Description

Event occurred on (b)(6) february no additional information provided.

• Brand Name: BD INTIMA-II 24GAX0.75IN 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: 18896879
• MDR Text Key: 337584365
• Report Number: 3002601200-2024-00081
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: (01)00382903830282
• 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: 04/17/2024

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: 383028
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1