MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE; PISTON SYRINGE

Model Number	305541
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Inaccurate Information (4051); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in some cases, the incorrect needles were received in the tray of bd¿ allergy syringes.In other cases, the labeling on the packaging was incorrect or missing information.Additionally, white or red fibers were found on the needle when removing the cap.The following information was provided by the initial reporter: "when you open up each individual tray some are actually the testing needles (1/2 ml 27g 3/8).We have seen this multiple times, as well as the opposite way, where we order testing needles.It says testing on the shipping box, but open each individual tray and it is treatment needles instead of testing.We have also had a few individual trays that have no label or print on them other than the lot and expiration date.Something even more concerning is that we have found so many treatment needles that when we pull off the cap, there is white or red fibers on the needle.".
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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 #1112184.All inspections were performed per the applicable operations qc specifications.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 capa/sa is required at this time.
Event or Problem Description
It was reported that in some cases, the incorrect needles were received in the tray of bd¿ allergy syringes.In other cases, the labeling on the packaging was incorrect or missing information.Additionally, white or red fibers were found on the needle when removing the cap.The following information was provided by the initial reporter: "when you open up each individual tray some are actually the testing needles (1/2 ml 27g 3/8).We have seen this multiple times, as well as the opposite way, where we order testing needles.It says testing on the shipping box, but open each individual tray and it is treatment needles instead of testing.We have also had a few individual trays that have no label or print on them other than the lot and expiration date.Something even more concerning is that we have found so many treatment needles that when we pull off the cap, there is white or red fibers on the needle.".

• Brand Name: BD¿ ALLERGY 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12847666
• Report Number: 1920898-2021-01214
• Device Sequence Number: 4351425
• Product Code: FMF
• UDI-Device Identifier: 30382903055419
• UDI-Public: 30382903055419
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 305541
• Device Catalogue Number: 305541
• Device Lot Number: 1112184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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