MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE

Catalog Number 300629

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2201110, medical device expiration date: 31dec2026, device manufacture date: 20jan2022.Medical device lot #: 2203035, medical device expiration date: 28feb2027, device manufacture date: 14feb2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd plastipak¿ syringes the syringe pump alarms during use.There was no report of patient impact.The following information was provided by the initial reporter: when the dps is started, the device triggers an occlusion alarm.The checks related to this type of alarm are carried out: valve assembly, non-occlusion of the central line.No anomaly was found.Finally, after several attempts to restart the system, the nurse changes the syringe pump and prepares a new syringe, but the system is not ready for use.And prepared a new syringe, but this time in a 50 ml bd plastipak syringe so that the device does not alarm while maintaining the pressure limits (set by default at p=300 mmhg and not changeable by users).

Manufacturer Narrative

D10: device available for eval yes.D10: returned to manufacturer on: 13jun2022.One used sample was returned to our quality team for investigation.The product was visually inspected, no damage or molding defect was observed that could have contributed to the reported issue.A device history review was performed for reported lot 2201110, no deviations or non-conformances related to this issue were identified during the manufacturing process.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station which helps facilitate easier movement of the plunger.The silicone employed in this product is a medical grade silicone authorized for product use.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.Testing results were reviewed for lot 2201110 and all results were found to be within required limits.Ten retained samples of lot 2201110 were used for additional evaluation.The product was visually inspected, no damaged or molding defects were observed and silicone content and breakout force testing verified product met required specifications.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see h.10.

Event Description

It was reported while using bd plastipak¿ syringes the syringe pump alarms during use.There was no report of patient impact.The following information was provided by the initial reporter: when the dps is started, the device triggers an occlusion alarm.The checks related to this type of alarm are carried out: valve assembly, non-occlusion of the central line.No anomaly was found.Finally, after several attempts to restart the system, the nurse changes the syringe pump and prepares a new syringe, but the system is not ready for use.And prepared a new syringe, but this time in a 50 ml bd plastipak syringe so that the device does not alarm while maintaining the pressure limits (set by default at p=300 mmhg and not changeable by users).

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14738824
• MDR Text Key: 294529226
• Report Number: 3003152976-2022-00275
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 2202066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1