MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SYRINGE

Catalog Number 305945

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported that the bd safetyglide syringe contained foreign matter.The following information was provided by the initial reporter: "they opened up one needle today (b)(6) 2023 and there was a greaselike substance on the needle itself.It was under the cap on the needle.They found it with one needle so far.They did document by taking photographs and will send in." additional information received on (b)(6) 23: 1.Any adverse event or serious injury reported to patient or healthcare professional? no 2.Was there a delay of, or change in, the course of treatment due to the event? no 3.Any sample or photo available for investigation? photos are available the physical needle was placed in a sharps container with other needles.4.How was the patient outcome? are there any clinical signs, health consequences or impact? no health consequences or impact, issue with needle was noticed before tb test placed and a new needle from a different lot number was used.5.How was treatment completed for customer? new needle from a different lot number was used.6.Patient status? fine 7.Any picture of this complaint yes and they are attached.8.Please explain elaborate issue? on opening of the sterile packet for the needle the rn noticed that there was a grease like substance under the needle cap.9.Date of event? (b)(6) 2023 10.Physical available/not available? not available 11.Lot number? 2136731 we have several boxes of this lot number can we get them replaced.With this issue my rns are not comfortable using needles from this lot.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD SAFETYGLIDE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18515181
• MDR Text Key: 333485571
• Report Number: 1920898-2024-00012
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: (01)30382903059455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305945
• Device Lot Number: 2136731
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• 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