MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL W/TWINPAK DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303393
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use needle coring occurred with a bd syringe 10ml ll w/twinpak device.The following information was provided by the initial reporter: it was reported that the needle cored when inserted into the vial.
Event or Problem Description
It was reported that during use needle coring occurred with a bd syringe 10ml ll w/twinpak device.The following information was provided by the initial reporter: it was reported that the needle cored when inserted into the vial.
Additional Manufacturer Narrative
H.6.Investigation summary: a single 10ml syringe with attached needle was received along with a mostly empty medication vial.The sample was visually evaluated.The vial was observed to have part of the septum separated inside the vial ¿ it appeared to be a bottom half of a multi part septum.The top half of the septum was still crimped to the vial and was observed to have a hole apparently from needle piercing.The septum was not a pre-slit type of septum.Small piece of cored septum was found inside the vial as well.The syringe was empty with only medication residue inside.Small pieces of septum were observed to be in the fluid path on top of the stopper.Potential root cause for coring needle is due to improper septum ¿ needle combination used.This product has a blunt point needle cannula which must be used with a pre-slit septum to avoid coring.Alternatively, a huber point style needle should be used to avoid coring.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 10ML LL W/TWINPAK DEVICE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9141226
• Report Number: 1213809-2019-00988
• Device Sequence Number: 11333273
• Product Code: FMI
• UDI-Device Identifier: 30382903033936
• UDI-Public: 30382903033936
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• 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): 12/02/2019

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: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 303393
• Device Lot Number: 9023692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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