MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 320469

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported that 5 bd ultra-fine¿ ii insulin syringes were unable to inject medication, and difficult to aspirate.The following information was provided by the initial reporter: consumer's husband reported wife attempted to inject her methotrexate with 5 different syringes for one injection last week.When the medication started to roll into syringe when drawing it.The plunger move back up on its own.Caller stated the needle was clogged.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 19-may-2022.H6: investigation summary: customer returned (4) 1ml bd insulin syringes from lot# 0237218.The customer reported that when the medication was drawn into the syringe the plunger moved back on its own, and the needle was clogged.All 4 returned samples were examined, and all 4 featured a clogged cannula as indicated by the plunger rod immediately returning to the 0- scale marking position after being drawn back.A wire test was performed on all 4 syringes.The wire could not make it through the length of the cannulas due to a hard material inside each cannula, indicating a possible adhesive clog.A review of the device history record was completed for batch# 0237218.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Embecta was able to duplicate or confirm the customer¿s indicated failure (clog).

Event Description

It was reported that 5 bd ultra-fine¿ ii insulin syringes were unable to inject medication, and difficult to aspirate.The following information was provided by the initial reporter: consumer's husband reported wife attempted to inject her methotrexate with 5 different syringes for one injection last week.When the medication started to roll into syringe when drawing it.The plunger move back up on its own.Caller stated the needle was clogged.

• Brand Name: BD ULTRA-FINE¿ II INSULIN SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14173702
• MDR Text Key: 289968231
• Report Number: 1920898-2022-00268
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320469
• Device Lot Number: 0237218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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