MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number 305916

Device Problem Leak/Splash (1354)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the bd safetyglide needle leaked.The following information was provided by the initial reporter: "during administration of menconc, syringe separated from needle and splashed on writer's hand and in dad's face.Writer had to administer another dose of menconc as full amount of initial dose not administered.1 inch needle lot number used was regq4058.Possible blocked needle.Issue not visible.No images available." 1st customer response when placing the needle on the syringe, did you give it a little twist? yes.Were you able to correct the issue using another needle? yes.2nd customer response was there any harm to the patient/caregiver? - patient had to get poked a second time for injection.Was there exposure to blood or chemotherapy to mucous membranes or skin? - no.Could you send photos and/or videos that show the deviation in the product? - not.Available.Was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, medication administration, etc.)? no.Are you able to provide any additional details? no additional details.

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, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

Additional info received 1st customer response ¿ when placing the needle on the syringe, did you give it a little twist? yes ¿ were you able to correct the issue using another needle? yes 2nd customer response - was there any harm to the patient/caregiver? - patient had to get poked a second time for injection.- was there exposure to blood or chemotherapy to mucous membranes or skin? - no - could you send photos and/or videos that show the deviation in the product? - not available.- was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, medication administration, etc.)? no - are you able to provide any additional details? no additional details.

• Brand Name: BD SAFETYGLIDE
• Type of Device: SAFETYGLIDE NEEDLES
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas NJ 88780 ; MX 88780
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18008055
• MDR Text Key: 326771570
• Report Number: 2243072-2023-01929
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059165
• UDI-Public: (01)30382903059165
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305916
• Device Lot Number: REGQ4058
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1