MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X3/4 RB; PISTON SYRINGE

Catalog Number	309569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A 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 the syringe 3ml ll w/ndl 22x3/4 rb experienced breakage during use.The following information was provided by the customer: verbatim: ¿she also reported a second lot # 8329966 where the needles are breaking off of the hub during their use.She did not know how many exactly (¿a few¿), said that they been ¿happening on different days¿ but did not know the dates.She did say that she will add 3 samples from this lot into the shipment for pr 801931.¿ see pr for additional details.Complaint summary detail: this is mdr reportable.The incident could have potential to cause harm/serious injury.The incident could have potential to impact medication delivery.Event type: breaks during use / malfunction.
Additional Manufacturer Narrative
The following field was updated due to corrected information describe event or problem: it was reported that the syringe 3ml ll w/ndl 22x3/4 rb experienced breakage during use.The following information was provided by the customer: verbatim: ¿she also reported a second lot # 8329966 where the needles are breaking off of the hub during their use.She did not know how many exactly (¿a few¿), said that they been ¿happening on different days¿ but did not know the dates.She did say that she will add 3 samples from this lot into the shipment for (b)(4).Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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 that the syringe 3ml ll w/ndl 22x3/4 rb experienced breakage during use.The following information was provided by the customer: verbatim: ¿she also reported a second lot # 8329966 where the needles are breaking off of the hub during their use.She did not know how many exactly (¿a few¿), said that they been ¿happening on different days¿ but did not know the dates.She did say that she will add 3 samples from this lot into the shipment for (b)(4).

• Brand Name: SYRINGE 3ML LL W/NDL 22X3/4 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8411919
• Report Number: 1213809-2019-00316
• Device Sequence Number: 1846586
• Product Code: FMF
• UDI-Device Identifier: 30382903095699
• UDI-Public: 30382903095699
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 04/23/2019

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: 10/31/2023
• Device Catalogue Number: 309569
• Device Lot Number: 8329966
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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