MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE

Catalog Number 326631

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

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd syringe 0.3ml 29ga 1/2in had foreign matter on the device cannula or in the fluid path.The following information was provided by the initial reporter : the customer reported that black dirt was found on the shield of the syringe.

Manufacturer Narrative

H6: investigation summary: customer returned (1) loose 3/10cc, 12.7mm syringe.Customer states that black dirt was found on the shield of the syringe.The returned syringe was examined and exhibited a black piece of material on the inner surface of the barrel.The barrel was cut to access this material.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.No spectral analysis could be obtained from this material, indicating that this material may be metallic in nature.A review of the device history record was completed for batch# 1061291.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure of foreign matter.Root cause: maintenance dispatch (l2l) #119438 was created for a loose airline.At the barrel cleaning dial, the top airline ¿blows¿ out the fm that may be present in the barrel.The airline was noted to be loose as it was ¿whipping¿ around.The operation was shut down immediately.Corrective action: replaced the airline fittings.H3 other text : see h10.

Event Description

It was reported that 1 bd syringe 0.3ml 29ga 1/2in had foreign matter on the device cannula or in the fluid path.The following information was provided by the initial reporter: the customer reported that black dirt was found on the shield of the syringe.

• Brand Name: BD SYRINGE 0.3ML 29GA 1/2IN
• Type of Device: PISTON 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12550204
• MDR Text Key: 274490610
• Report Number: 1920898-2021-01028
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: Lay User/Patient
• Device Catalogue Number: 326631
• Device Lot Number: 1061291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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