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

Model Number	329408
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd ultra-fine¿ ii short needle insulin syringe, the device experienced foreign matter on device cannula / in fluid path , plunger movement difficult, leakage, failure of product to contain medication (i.E.Crack, hole, cut, etc.) the following information was provided by the initial reporter.The customer stated: it was reported that there was a red substance in the barrel of syringes.Syringes were missing needle.One syringe could not pull plunger out of syringe.Also reported one syringe leaked medication.Two syringes had cracked barrels.Consumer reported on 1 syringe found red substances in the barrel of syringes.-lot #: 8253834d.Consumer reported found 3 without a needle when removed shield, shield removal went as normal.-lot #: 9098718 - lot # 9343440d & lot # 8316615b.Consumer reported found 1 syringe could not pull plunger out of syringe.-lot #: 6347519a.Consumer reported found 1 syringe medication leaked out the top of syringe when in use/ plunger area.-lot #: 9042896a.Consumer reported caller found 1 syringe needle missing consumer reported found 2 syringes with cracked barrels lot #: 1144233c.
Additional Manufacturer Narrative
Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8253834; medical device expiration date: 2023-09-30; device manufacture date: 2018-09-10.Medical device lot #: 9098718; medical device expiration date: 2024-07-31; device manufacture date: 2019-04-08.Medical device lot #: 9343440; medical device expiration date: 2024-12-31; device manufacture date: 2019-12-09.Medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.Medical device lot #: 6347519; medical device expiration date: na; device manufacture date: 2016-02-17.Medical device lot #: 9042896; medical device expiration date: 2024-02-29; device manufacture date: 2019-02-11.Medical device lot #: 1144233; medical device expiration date: 2026-06-30; device manufacture date: 2021-05-24.
Event or Problem Description
It was reported when using the bd ultra-fine¿ ii short needle insulin syringe, the device experienced foreign matter on device cannula / in fluid path , plunger movement difficult, leakage, failure of product to contain medication (i.E.Crack, hole, cut, etc.) the following information was provided by the initial reporter.The customer stated: it was reported that there was a red substance in the barrel of syringes.Syringes were missing needle.One syringe could not pull plunger out of syringe.Also reported one syringe leaked medication.Two syringes had cracked barrels.Consumer reported on 1 syringe found red substances in the barrel of syringes.-lot #: 8253834d.Consumer reported found 3 without a needle when removed shield, shield removal went as normal.-lot #: 9098718 - lot # 9343440d & lot # 8316615b.Consumer reported found 1 syringe could not pull plunger out of syringe.-lot #: 6347519a.Consumer reported found 1 syringe medication leaked out the top of syringe when in use/ plunger area.-lot #: 9042896a.Consumer reported caller found 1 syringe needle missing.Consumer reported found 2 syringes with cracked barrels.Lot #: 1144233c.
Additional Manufacturer Narrative
H6: investigation summary.Customer returned (3) 1/2cc, 8mm, 31g syringes in an open poly bag from lot # 1144233.Customer states that the barrels are cracked.All returned syringes were examined and one sample exhibited cracks in the barrel running from the 45 unit marking to the flange.Customer returned (1) 1/2cc, 8mm, 31g syringe in an open poly bag from lot # 9042896.Customer states that the syringe leaked medication.The returned syringe was tested and was able to draw and expel properly without any observed defects.Ustomer returned (1) 1/2cc, 8mm, 31g syringe in an open poly bag from lot # 6347519.Customer states that they could not pull plunger out of syringe.The returned syringe was examined and exhibited a deformed plunger rod.Customer returned (1) loose 1/2cc, 8mm, 31g syringe in an open poly bag from lot # 8253834.Customer states that there was a red substance in the barrel of syringes.The returned syringe was examined and no foreign matter was observed.However, the sample exhibited an air bubble embedded in the plastic of the barrel.A review of the device history record was completed for batch# 1144233.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 9042896.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.A review of the device history record was completed for batch# 6347519.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications noted that did not pertain to the complaint.A review of the device history record was completed for batch# 8253834.All inspections and challenges were performed per the applicable operations qc specifications.There were six (6) notifications noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (cracked barrel).Bd was not able to duplicate or confirm the customer¿s indicated failure syringe leaked medication.Bd was able to confirm the customer¿s indicated failure (deformed plunger rod).Bd was able to confirm the customer¿s indicated failure air bubble embedded in the plastic of the barrel.Root cause could not be determined.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE
• Common Device Name: 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: 13256399
• Report Number: 1920898-2021-01402
• Device Sequence Number: 5022866
• Product Code: FMF
• UDI-Device Identifier: 00382903294084
• UDI-Public: 00382903294084
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K010890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 329408
• Device Catalogue Number: 329408
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown