MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE; ALLERGY SYRINGE AND NEEDLE

Catalog Number	305500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a 1 ml allergy syringe with 28 g x 1/2 in.Bd precisionglide¿ permanently attached needle broke off in the vial while drawing the medication.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Investigation: customer returned (1) 1cc allergy syringe with part of the shelf carton from lot # 6291877.Customer states that the needle broke in the vial.The returned syringe was examined and exhibited a detached cannula.The loose cannula was returned in the shield of the syringe.The sample was examined under the microscope and exhibited adhesive runoff onto the hub.Little adhesive was observed in the hub.Adhesive was also observed on the cannula shaft.A review of the device history record was completed for batch #6291877.All inspections were performed per the applicable operations qc specifications.The sample was forwarded to manufacturing ((b)(4)) on 17nov2017 for further review.On 21nov2017, (b)(4) received one (1) 1mlallergy syringe and a portion of a shelf carton from batch# 6291877.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, no additional findings to those found in (b)(4) were noted.Probable root cause is a misalignment during adhesive application on the pils (point inspect lube shield) machine.Capa (b)(4) was initiated by the (b)(4) plant to address adhesive runover/shield difficult to remove and their associated root cause(s).Probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive runover onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.

• Brand Name: 1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: ALLERGY SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 6956153
• Report Number: 1920898-2017-00256
• Device Sequence Number: 633930
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 305500
• Device Lot Number: 6291877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/08/2017
• 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