MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSHIFLUSH XS; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Material Deformation (2976)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that the bd poshiflush xs was damaged.Report 2 of 2 the following was received by the initial reporter: several syringes of this batch block when emptying.This means that a strong resistance occurs after approx.Half of the syringe.We have an example on our premises.This always causes confusion for the customer.Since there are 2 options.Either the catheter is blocked.Or the syringe is not in order.The catheter has been checked.The syringes are slightly crooked.We suspect a connection.There has been no patient damage so far.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(4).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 19-jul-2023.H6: investigation summary: a device history record review was completed for provided material number 306572 and lot number 3054816.The review did not reveal any possible non-conformances that could have contributed to this incident.To aid in the investigation of this issue, one (1) sample was returned for evaluation by our quality team.The syringe sample was outside of its packaging and 8.5ml of saline had been expelled.Force testing was completed on the returned sample and no signs of plunger movement difficulty could be identified.Through visual inspection of the syringe, we were unable to confirm the reported defect of crooked syringe/plunger.At this time, an exact cause could not be determined for the reported issues.

Event Description

It was reported that the bd poshiflush xs was damaged.Report 2 of 2.The following was received by the initial reporter: several syringes of this batch block when emptying.This means that a strong resistance occurs after approx.Half of the syringe.We have an example on our premises.This always causes confusion for the customer.Since there are 2 options.Either the catheter is blocked.Or the syringe is not in order.The catheter has been checked.The syringes are slightly crooked.We suspect a connection.There has been no patient damage so far.

• Brand Name: BD POSHIFLUSH XS
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17283852
• MDR Text Key: 319393596
• Report Number: 9616657-2023-00019
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/28/2023

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 Catalogue Number: 306572
• Device Lot Number: 3054816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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