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

Model Number 328418

Device Problem Crack (1135)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported when using the bd insulin syringe with the bd ultra-fine¿ needle, the device experienced failure to contain blood / medication / (crack or hole in the syringe).This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: it was reported by the consumer, the insulin leaked out and the barrel was cracked.  consumer reported, when taking injection, insulin leaked out.Stated, she noticed the barrel was cracked.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 1130214.All inspections were performed per the applicable operations qc specification.There was one (1) notification noted that did not pertain to the complaint.H3 other text : see h10.

Event Description

It was reported when using the bd insulin syringe with the bd ultra-fine¿ needle, the device experienced failure to contain blood / medication / (crack or hole in the syringe).This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: it was reported by the consumer, the insulin leaked out and the barrel was cracked.  consumer reported, when taking injection, insulin leaked out.Stated, she noticed the barrel was cracked.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-06.H6: investigation summary: customer returned (2) loose 1ml bd insulin syringes.The consumer reported, when taking injection, insulin leaked out, and she noticed the barrel was cracked.The returned syringes were examined, and it was observed that both exhibited cracks along the length of the barrel.The cracks along the barrels could have led to the leakage experienced by the consumer.A review of the device history record was completed for batch# 1130214.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure.Root cause: leading 2learn(l2l) # 124629 for damaged barrels.H3 other text : see h10.

Event Description

It was reported when using the bd insulin syringe with the bd ultra-fine¿ needle, the device experienced failure to contain blood / medication / (crack or hole in the syringe).This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: it was reported by the consumer, the insulin leaked out and the barrel was cracked.  consumer reported, when taking injection, insulin leaked out.Stated, she noticed the barrel was cracked.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• 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: 12930116
• MDR Text Key: 282112022
• Report Number: 1920898-2021-01271
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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,Followup
• Report Date: 01/24/2022

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 Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: 1130214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 01/24/2022
• Supplement Dates FDA Received: 12/30/2021; 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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
• Patient Sex: Female