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

Catalog Number	305541
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ allergy syringe had a discolored needle.The following information was provided by the initial reporter: "customer called stating that they received a defective product.".
Additional Manufacturer Narrative
H.6.Investigation summary: photos and (1195) 1ml, 10mm, 27g bd allergy syringes (1125 in sealed trays, 70 in open trays) were received along with the reported complaints of needle discoloration/variation in color/cloudy.The investigating team has used the photos and samples of item #305541 and lot #2011725 for investigating the reported defects.The photos and thirty out of 1195 returned syringes were examined and no needle discoloration were observed.A review of the device history record was completed for batch #2011725.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 and/or photo(s) received the investigation concluded that embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issues are unconfirmed.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd¿ allergy syringe had a discolored needle.The following information was provided by the initial reporter: "customer called stating that they received a defective product.".
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: allergy syringe.Device failure: discoloration / variation in color/cloudy.
Event or Problem Description
No additional information.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15227709
• Report Number: 1920898-2022-00549
• Device Sequence Number: 20234730
• Product Code: FMF
• UDI-Device Identifier: 30382903055419
• UDI-Public: (01)30382903055419(11)220111(17)270228(10)2011725
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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 Catalogue Number: 305541
• Device Lot Number: 2011725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/23/2022; Not provided
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/12/2022; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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