MAUDE Adverse Event Report: BD SUZHOU (MDS) BD UNKNOWN SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	UNKNOWN
Medical Device Problem Codes	Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd unknown saf-t-intima drip set with safety catheter stylet separated from needle hereby i would like to inform you of an incident that took place with a patient in our home care organisation.It concerns the product: bd saf-t-intima drip set with safety catheter.Unfortunately, i no longer have the packaging with the serial number.Incident description: after inserting the subcutaneous drip set, i wanted to remove the needle via the safety system.While removing the needle, the system broke in half.The needle was still in the end of the infusion tube and the thin iron wire with white cap had broken off from the needle and was in my hands.I did not expect that with a safety catheter infusion set, something could break off, this made the product unsafe and uncomfortable to work with at this point.I had to remove the drip set from the patient and the patient had to be re-pricked.Unfortunately, i can no longer determine the serial number, but i would like to pass on this incident so that you are informed.I would like to hear your reaction and whether a similar incident has happened more often.
Event or Problem Description
No additional informaiton provided.
Additional Manufacturer Narrative
A complaint history check was unable to be performed since no material, lot/batch number was provided.A device history review was unable to be performed since no material, lot/batch number was provided.A review of the applicable risk documentation indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.A retain sample analysis could not be performed as no material, batch/lot number was made available for this reported event.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.

• Brand Name: BD UNKNOWN SAF-T-INTIMA
• Common Device Name: 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: 19932831
• Report Number: 3002601200-2024-00375
• Device Sequence Number: 16825596
• Product Code: FOZ
• UDI-Device Identifier: 00382903833351
• UDI-Public: (01)00382903833351
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown