MAUDE Adverse Event Report: BD POSIFLUSH¿ NS FILLED SYRINGE; INTRAVASCULAR CATHETER

Model Number 306546

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1116332.Medical device lot #: 1116333.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 when using the bd posiflush¿ ns filled syringes the plunger movement was difficult with six syringes.The following information was provided by the initial reporter.The customer stated: "the bd prefilled syringes did not function.The nurse will be flushing with the 10ml ns syringe and about ½ way or when it gets down to 2-3 ml left in the syringe, it just stops.You can push on the plunger very hard and it will not go.You can pull back and get a blood return, but when you go to flush it won¿t go past the 2-3 ml mark.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-11.H6: investigation summary: it was reported that six bd prefilled syringes did not function.To aid in the investigation, two samples with the packaging blister top web were received for evaluation by our quality team.The packaging blister top web identifies the products as bd saf-t intima, material 383313, lot 1053935.The samples returned are not related to this complaint and no further analysis was performed.For the plunger movement defect, it could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number 306546, lot number 1116333.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported when using the bd posiflush¿ ns filled syringes the plunger movement was difficult with six syringes.The following information was provided by the initial reporter.The customer stated: "the bd prefilled syringes did not function.The nurse will be flushing with the 10ml ns syringe and about ½ way or when it gets down to 2-3 ml left in the syringe, it just stops.You can push on the plunger very hard and it will not go.You can pull back and get a blood return, but when you go to flush it won¿t go past the 2-3 ml mark.".

• Brand Name: BD POSIFLUSH¿ NS FILLED SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12407780
• MDR Text Key: 270640072
• Report Number: 1911916-2021-00908
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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