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

Catalog Number	305541
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inaccurate label information was found on a bd¿ allergy syringe box.No patient impact reported.The following information was provided by the initial reporter: we frequently have boxes that are printed on the outside as treatment syringes when opened the packs may be printed as treatment upon opening they may be testing syringes and vice/ versa.
Additional Manufacturer Narrative
Date of event is unknown.The date received by manufacturer has been used for this field.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: photos and (1195) 1ml, 10mm, 27g bd allergy syringes (1125 in sealed trays, 70 in open trays), product code #305541 and lot # 2011725 were received along with the reported complaint of mixed product/lots.The photos and trays were examined, and no mixed product was 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 issue is unconfirmed.Based on the above, no additional investigation and no capa/sa is required at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that inaccurate label information was found on a bd¿ allergy syringe box.No patient impact reported.The following information was provided by the initial reporter: we frequently have boxes that are printed on the outside as treatment syringes when opened the packs may be printed as treatment upon opening they may be testing syringes and vice/ versa.

• 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: 15229689
• Report Number: 1920898-2022-00552
• Device Sequence Number: 6293137
• Product Code: FMF
• UDI-Device Identifier: 00382903055418
• UDI-Public: 00382903055418
• 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
• Report Date (Section B): 08/23/2022

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: Other
• Device Catalogue Number: 305541
• Device Lot Number: UNKNOWN
• 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
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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