MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGES WITHOUT NEEDLES; PISTON SYRINGE

Catalog Number	303134
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd¿ slip tip syringes without needles had sterile breach due to a broken seal on the packaging.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that bd slip tip syringes without needles had sterile breach due to a broken seal on the packaging.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
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.Two packaged syringes were received, confirmed to be from batch #8099664 (p/n 303134).They were visually evaluated.One package was almost completely peeled opened on 3 sides and the syringe was loose in the bag.The second package had an opened seal on one long side.Close evaluation did not reveal any seal anomalies or abnormalities ¿ the seal grid was present in full on the bottom web along with its corresponding prior location on the top web clearly identifiable.Bottom web showed signs of stress ¿ squeeze or stretch marks ¿ on the peel tab side of the package surrounding the flange in a u shape.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.The potential root cause for the open seal defect is likely due to the incorrect stacking of packages by the offload system, which is due to a design flaw in one of its components.Corrective actions, short term: affected component has been fixed.Long term: redesign of the component by vendor to prevent the failure mode from occurring.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.

• Brand Name: BD¿ SLIP TIP SYRINGES WITHOUT NEEDLES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7766262
• Report Number: 1213809-2018-00525
• Device Sequence Number: 1793874
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: 382903031344
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 303134
• Device Lot Number: 8099664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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