MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II; PERIPHERAL IV CATHETERS

Catalog Number 383028

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported the bd intima-ii contained a damaged heparin (prn) connector.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) 2023 20:00 the nurse was preparing to perform indwelling venipuncture on the child, opened the indwelling needle, and found that the heparin cap was damaged.

Event Description

"please conduct follow-up: 1) it was reported that the heparin cap was found damaged while preparing for the venipuncture.Was the device still used on the patient or was it not used? 2) how was the heparin cap damaged? please elaborate (e.G.Hard plastic broken, connector loose, prn septum swollen, prn septum split, etc.) 3) was there any serious injuries or adverse events related to this event? if so, what? 4) were medical or surgical interventions required due to this event? if so, what? 5) was there a delay or change of treatment due to this event? 6) was there blood or body fluid exposure to a wound or mucosal surface of another individual?"7)sample ------------------------------ 1 no 2.Hard plastic broken is broken 3 ~ 8 no information provided due to too long time no additional information provided.

Manufacturer Narrative

A complaint history review cannot be performed as no batch/lot number was provided.A device history record(dhr) review could not be performed as no batch/lot number was made available for this reported event.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.Ar-code--a review of the applicable  risk documentation indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation-s.Davidson.Root cause couldn't be determined due to unavailability of sample and batch/lot number information.

• Brand Name: BD INTIMA-II
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18935405
• MDR Text Key: 338442774
• Report Number: 3002601200-2024-00090
• 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: 04/11/2024

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: Health Professional
• Device Catalogue Number: 383028
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1