MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G U-100; PISTON SYRINGE

Model Number 328411

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Investigation summary: a complaint lot history check was performed on lot # 1158775 for breaks off during use.This is the 1st related complaint for breaks off during use on lot # 1158775.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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 1158775.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that two times during use a bd insulin syringes with bd ultra-fine¿ needle 1ml 12.7mm (1/2") 30g u-100 100 count, the needle broke.The following information was provided by the initial reporter: sometimes needle breaks.Caller is able to remove the 2 needle breaks in skin.No medical attention is needed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 29-apr-2022 h6: investigation summary customer returned an unopened polybag of (10) 1ml, 30 gauge, 12.7mm syringes from lot 1158775.30 of the returned samples were inspected to ensure that using them was as least harmful as intended.The outer diameters of these needles were measured, the results of which are featured below: 1.0.0125 in 2.0.0125 in 3.0.0124 in 4.0.0123 in 5.0.0125 in 6.0.0124 in 7.0.0124 in 8.0.0124 in 9.0.0123 in 10.0.0124 in all of the needles were measured within acceptable outer diameters for 30 gauge needles (0.0120 in to 0.0125 in).The integrity of each needle point was inspected and no defects were found.No debris was found at the tip of any of the needles.Each needle was tested on a skin analog and none of the needles were damaged.Lastly, flour was applied to the needles¿ cannulas to ensure that lubricant was present.Sufficient lubricant was found on all samples.No damage to the needles of any kind was observed and all functioned as intended.The needles were within specifications and did not feature any dullness or burrs that could result in patient harm.A review of the device history record was completed for batch# 1158775.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of blunt needles.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

Event Description

It was reported that two times during use a bd insulin syringes with bd ultra-fine¿ needle 1ml 12.7mm (1/2") 30g u-100 100count, the needle broke.The following information was provided by the initial reporter: sometimes needle breaks.Caller is able to remove the 2 needle breaks in skin.No medical attention is needed.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G U-100
• 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: 14226728
• MDR Text Key: 290449147
• Report Number: 1920898-2022-00292
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• 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: 05/24/2022

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: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 1158775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1