MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 10ML SYRINGE LUER-LOK TIP

Catalog Number 305959

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd 10ml syringe luer-lok¿ tip does not fit correctly in the pump causing sound alarms.

Manufacturer Narrative

Investigation: two used samples were returned to our quality engineer for investigation.The product was visually inspected, not identifying any damage or molding defect that could have contributed to this malfunction.A device history review was performed for reported lot 1810009 ,no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Manufacturing records established that quality processes were carried out normally, testing performed on the product throughout the manufacturing process verified product was within required specifications.Based on the available information we were not able to determine a root cause at this time.

Event Description

It was reported that a bd 10ml syringe luer-lok¿ tip does not fit correctly in the pump causing sound alarms.

Event Description

It was reported that a bd 10ml syringe luer-lok¿ tip does not fit correctly in the pump causing sound alarms.

Manufacturer Narrative

H.6.Investigation summary: no sample or picture have been received for investigation.Dhr of lot 1810009 has been reviewed not finding any annotation or deviation regarding the alleged defect.Silicone content, break out and sustaining force tests are done to every lot during manufacturing process.Minimum reference value for silicone content in 10ml ll syringes is 2mg and maximum limit is 7mg.Maximum limit for break out and sustaining force test are 4,5 lb and 2 lb respectively according to procedure jg-500.Results for these tests during manufacturing process of lot 1810009 are checked finding them within the procedure limits previously mentioned.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): 1.Visual inspection: molding: 2 injections per shift.Printing: 24 samples per hour, after any intervention in the equipment and once at the beginning of the shift.Assembly: 24 samples per hour, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.2 functional inspection.Printing: once in the first pallet and once in the last pallet of the lot.Assembly: once in the first pallet and once in the last pallet of the lot.Primary packaging: once in the first pallet and once in the last pallet of the lot.Since no sample has been received and test results during manufacturing process of this lot were within specification limits, the root cause of this incident cannot be determined.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 quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8287265
• MDR Text Key: 134574372
• Report Number: 3003152976-2019-00119
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 305959
• Device Lot Number: 1810009
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other