MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 20ML SYRINGE LUER-LOK; PISTON SYRINGE

Catalog Number 300629

Device Problems Volume Accuracy Problem (1675); Inappropriate Audible Prompt/Feedback (2280)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

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.Fda device problem code(s): (b)(4), (b)(4), fda patient problem code(s): (b)(4).

Event Description

It was reported that during use, the syringe pump alarms and there is still 1 ml of medication left with a bd plastipak¿ 20 ml syringe luer-lok¿.The following information was provided by the initial reporter, translated from (b)(6) to english: the syringe shows such resistance that the occlusion pressure alarm goes off.It is checked with another batch and no such problem occurs.When the infusion ends, just 1 ml remains in the syringe without infusing.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-07-27.H.6.Investigation summary: two unused samples, one photo, and one video was provided to our quality team for investigation.Upon visual inspection, the stopper was properly assembled onto the plunger and no damage or molding defects were observed in the syringe that could have contributed to the reported incident.A device history review was performed for reported lot 1907210, no deviations or non-conformances related to this issue were identified during the manufacturing process.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.Results for the reported lot were reviewed and found to be within required specifications.Additionally, testing was performed on the returned sample and results were found to be acceptable.Based on the available information we are not able to determine a root cause at this time.Since no issues were identified and manufacturing record established that all production and quality processes were carried out normally, and tests performed with unused sample received are within specification limits, no corrective action is taken at this time.Based on qda limits for this product and defect no corrective action is required at this time.H3 other text : see h.10.

Event Description

It was reported that during use, the syringe pump alarms and there is still 1ml of medication left with a bd plastipak¿ 20ml syringe luer-lok¿.The following information was provided by the initial reporter, translated from spanish to english: the syringe shows such resistance that the occlusion pressure alarm goes off.It is checked with another batch and no such problem occurs.When the infusion ends, just 1 ml remains in the syringe without infusing.

• Brand Name: BD PLASTIPAK 20ML SYRINGE LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10314475
• MDR Text Key: 201912978
• Report Number: 3003152976-2020-00321
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 1907210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other