MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOK; SYRINGE

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported bd eclipse¿ injection needle with luer-lok¿ syringe needle was blocked the patient went to see a doctor on (b)(6) 2023.The main reason was that he had a fever for one day.The antipyretic medicine he took by himself was not effective.The doctor gave the antipyretic medicine intramuscular injection.When absorbing the medicine, it was found that the needle was blocked.He treated it as medical waste and replaced the needle immediately.Absorb the liquid.

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.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

No additional information received the patient went to see a doctor on (b)(6) 2023.The main reason was that he had a fever for one day.The antipyretic medicine he took by himself was not effective.The doctor gave the antipyretic medicine intramuscular injection.When absorbing the medicine, it was found that the needle was blocked.He treated it as medical waste and replaced the needle immediately.Absorb the liquid.

• Brand Name: BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOK
• Type of Device: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18094110
• MDR Text Key: 327771613
• Report Number: 2243072-2023-02018
• Device Sequence Number: 1
• Product Code: FMF
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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