MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1/2ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305535
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: customer returned two (2) opened/used bd allergy syringe trays for 0.5ml, 27gx0.5¿ syringes from lot 9144518.Customer reported that received product is incorrectly labeled.The 0.5ml syringes inside each returned syringe tray were examined, then tested for cannula length and outer diameter.All 50 tested syringes tested within specification regarding cannula length and outer diameter as displayed on the syringe tray labels.No evidence of manufacturing defect was observed.Since no defects were observed, the alleged issue could not be confirmed.A review of the device history record was completed for batch # 9144518.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 9144518.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the box of syringes allergy 1/2ml w/ndl 27x1/2 rb was incorrectly labeled as bd5540 1cc, 27g x ½¿ regular bevel syringes.This was noticed prior to use.The following information was provided by the initial reporter: "in regards to item no.Bd5536 1/2cc, 27g x 3/8¿ intradermal bevel syringes, lot no.9144518, they are incorrectly labeled as bd5540 1cc, 27g x ½¿ regular bevel syringes.The box has been recycled so i cannot verify the label was correct, but we unbox these syringes for use at separate locations in our office, and they were in the correct place.".

• Brand Name: SYRINGE ALLERGY 1/2ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10659743
• Report Number: 1920898-2020-01386
• Device Sequence Number: 11745968
• Product Code: FMF
• UDI-Device Identifier: 30382903055358
• UDI-Public: 30382903055358
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 05/31/2024
• Device Model Number: 305535
• Device Catalogue Number: 305535
• Device Lot Number: 9144518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other