MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/22/2022

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 #: 2115276.Medical device expiration date: 30-apr-2025.Device manufacture date: 25-apr-2022.Medical device lot #: 2115277.Medical device expiration date: 30-apr-2025.Device manufacture date: 25-apr-2022.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 1 bd posiflush¿ normal saline syringe each from lots 2115276, 2115277, and an unspecified lot had difficult plunger movement during the flush.The following information was provided by the initial reporter: "3 instances in which end-user encountered resistance when attempting to push plunger to flush line.".

Manufacturer Narrative

Correction.B3: date of event: 22-jun-2022.

Event Description

It was reported that 1 bd posiflush¿ normal saline syringe each from lots 2115276, 2115277, and an unspecified lot had difficult plunger movement during the flush.The following information was provided by the initial reporter: "3 instances in which end-user encountered resistance when attempting to push plunger to flush line.".

Event Description

It was reported that 1 bd posiflush¿ normal saline syringe each from lots 2115276, 2115277, and an unspecified lot had difficult plunger movement during the flush.The following information was provided by the initial reporter: "3 instances in which end-user encountered resistance when attempting to push plunger to flush line.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 10-jan-2022.H6.Investigation summary: it was reported there was resistance when attempting to push the plunger to flush a line.To aid in the investigation, three empty samples with no packaging flow wraps or tip caps were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The samples were then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the results were within specification.A device history record review was completed for provided material number 306546, lot numbers 2115277 & 2115276.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.

Event Description

It was reported that 1 bd posiflush¿ normal saline syringe each from lots 2115276, 2115277, and an unspecified lot had difficult plunger movement during the flush.The following information was provided by the initial reporter: "3 instances in which end-user encountered resistance when attempting to push plunger to flush line.".

Manufacturer Narrative

H6.Investigation summary: it was reported there was resistance when attempting to push the plunger to flush a line.As a sample was unavailable for return, a thorough sample investigation could not be completed.It could be possible that the customer is getting some products that are towards the high specification limit for plunger movement 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 2115277.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.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15963148
• MDR Text Key: 308349944
• Report Number: 1911916-2022-00724
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 50382903065467
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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