MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE INTEGRA 25X5/8 RB TW; PISTON SYRINGE

Catalog Number	305310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 needle integra 25x5/8 rb tw had leakage.The following was reported, "material no.305310; batch no.7027897.It was reported there was leakage."administered mmr vaccine with bd integra 3ml syringe and bd integra retracting needle combo.When administering mmr on the right thigh, the vaccine liquid leaked from the hub of the needle.The needle was properly screwed on and fully inserted into the subcutaneous tissue of the thigh.Unable to verify how much vaccine was administered into the patient.Per rn the patient will need to repeat the mmr vaccine in order to ensure the child received the proper dose of mmr.".
Additional Manufacturer Narrative
Investigation summary: a device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.No samples or photos were provided by the customer for investigation.No samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.
Event or Problem Description
It was reported that a needle integra 25x5/8 rb tw had leakage.The following was reported, "material no.305310.Batch no.7027897.It was reported there was leakage."administered mmr vaccine with bd integra 3ml syringe and bd integra retracting needle combo.When administering mmr on the right thigh, the vaccine liquid leaked from the hub of the needle.The needle was properly screwed on and fully inserted into the subcutaneous tissue of the thigh.Unable to verify how much vaccine was administered into the patient.Per rn the patient will need to repeat the mmr vaccine in order to ensure the child received the proper dose of mmr.".

• Brand Name: NEEDLE INTEGRA 25X5/8 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8457927
• Report Number: 1911916-2019-00312
• Device Sequence Number: 2839626
• Product Code: MEG
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (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): 04/05/2019

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 305310
• Device Lot Number: 7027897
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/07/2019
• 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