MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB; SAFETY SYRINGE W/ NEEDLE

Model Number	305906
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: additional fda product code fmi (needle).Multiple 510k's: k980987(syringe); k951254 (needle).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 a syringe 3ml ll w/ndl sftygld 22x1-1/2 rb was found sticking out of the sterile packaging.
Event or Problem Description
It was reported a syringe 3ml ll w/ndl sftygld 22x1-1/2 rb was found sticking out of the sterile packaging.
Additional Manufacturer Narrative
Investigation summary: one sealed safetyglide combo package was received, confirmed to be from batch #9270295 (p/n 305906).The sample was visually evaluated.There was an extra needle of the same gauge and length present inside the package.The needle was sharing the cavity pocket with the syringe, had no shield, with its cannula protruding halfway through the bottom web.The cannula was also bent approximately 45 degrees at the point where it exited the package.The potential root cause for the extra part in the package is lack of proper part containment above the open blisters during the packaging process.Additional barriers will be installed around the identified moving parts handling system to improve parts containment and to prevent any accidental parts from falling into the open blisters during the packaging process.Furthermore, 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
Investigation: one sealed safetyglide combo package was received, confirmed to be from batch #9270295 (p/n 305906).The sample was visually evaluated.There was an extra needle of the same gauge and length present inside the package.The needle was sharing the cavity pocket with the syringe, had no shield, with its cannula protruding halfway through the bottom web.The cannula was also bent approximately 45 degrees at the point where it exited the package.The potential root cause for the extra part in the package is lack of proper part containment above the open blisters during the packaging process.Additional barriers will be installed around the identified moving parts handling system to improve parts containment and to prevent any accidental parts from falling into the open blisters during the packaging process.Furthermore, 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.
Event or Problem Description
It was reported a syringe 3ml ll w/ndl sftygld 22x1-1/2 rb was found sticking out of the sterile packaging.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
• Common Device Name: SAFETY SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9727856
• Report Number: 1213809-2020-00114
• Device Sequence Number: 3069097
• Product Code: FMF
• UDI-Device Identifier: 30382903059066
• UDI-Public: 30382903059066
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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: 08/31/2024
• Device Model Number: 305906
• Device Catalogue Number: 305906
• Device Lot Number: 9270295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 01/25/2020; 01/25/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/20/2020; 03/26/2020
• 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