MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305924
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8119703; medical device expiration date: 2023-04-30; device manufacture date: 2018-04-29.Medical device lot #: 8064678; medical device expiration date: 2023-02-28; device manufacture date: 2018-03-05.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 with the use of the bd safetyglide¿ shielding hypodermic needle there was an issue with incorrect needle length.There was no report of injury or further medical intervention.
Event or Problem Description
It was reported with the use of the bd safetyglide shielding hypodermic needle there was an issue with incorrect needle length.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Six sealed 3ml safetyglide combo syringe with needle packages were received, confirmed to be from batch #8119703 (p/n 305924).They were visually evaluated.The needles were all properly shielded with no visual defects observed.Packages were opened and needle length was checked using cannula length chart.All cannulas¿ injectable lengths were within the product specification of 1¿ for this product.The needles are 25g, which are relatively thin needles and will flex more easily than needles with a lower gauge number.It is important to note that the product¿s cannula length is the ¿injectable length¿ which is considered prior to shield extension.Device history record review showed no rejected inspections or quality issues during the production of the provided two lot number that could have contributed to the reported defect.The reported defect was not identified in the samples received.Unable to determine a root cause.Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

• Brand Name: BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• 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: 7786196
• Report Number: 1213809-2018-00548
• Device Sequence Number: 1195576
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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 Catalogue Number: 305924
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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