MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Loose or Intermittent Connection (1371); Failure to Deliver (2338)

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

Event Date 08/21/2022

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed.And the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd ultra-fine¿ insulin syringe plunger stopper was loose, which made medication delivery difficult.The following information was provided by the initial reporter: " i've been using bd ultra fine insulin syringes (3/10ml / 8mm / 31g) for over two years for my diabetic dog.On occasion i would get a syringe where the little stopper keeps sliding down so i can't draw a correct dose.I would just throw it away and use a new one.However, this last box of 100 syringes has had more defective ones than good ones.In the last two days i've had to dispose of six syringes because the stopper kept sliding down and couldn't be fixed which means i can't measure the dose.".

Event Description

It was reported that the unspecified bd ultra-fine¿ insulin syringe plunger stopper was loose, which made medication delivery difficult.The following information was provided by the initial reporter: " i've been using bd ultra fine insulin syringes (3/10ml / 8mm / 31g) for over two years for my diabetic dog.On occasion i would get a syringe where the little stopper keeps sliding down so i can't draw a correct dose.I would just throw it away and use a new one.However, this last box of 100 syringes has had more defective ones than good ones.In the last two days i've had to dispose of six syringes because the stopper kept sliding down and couldn't be fixed which means i can't measure the dose.".

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.

• Brand Name: UNSPECIFIED BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15433041
• MDR Text Key: 300786563
• Report Number: 2243072-2022-01523
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/03/2022
• 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