MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SURESCRUB¿ SALINE SYRINGE; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number 306546

Device Problem Difficult to Flush (1251)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H.3.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 posiflush¿ surescrub¿ saline syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: the customer reports it is difficult to use saline flushes.When they push on plunger there is a resistance, instead of smooth flow there is a turbulent flow.Customer's preference of communication is email.

Manufacturer Narrative

H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3142760.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported while using bd posiflush¿ surescrub¿ saline syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: the customer reports it is difficult to use saline flushes.When they push on plunger there is a resistance, instead of smooth flow there is a turbulent flow.Customer's preference of communication is email.

Event Description

(b)(4) additional information received.Material #: 306546, batch #: 3142760.It was reported by the customer that when they push on plunger there is a resistance, instead of smooth flow there is a turbulent flow.Verbatim: rcc received a complaint via phone.Pir attached.The customer reports it is difficult to use saline flushes.When they push on plunger there is a resistance, instead of smooth flow there is a turbulent flow.Customer's preference of communication is email.Ref# 306559.Lot# 3142760.Response received on 20-sep-2023 are you able to provide the date of incident? (b)(6) 2023.Please confirm if the batch number provided 3142760 is the correct number? it was not detected in our system for product 306559.Lot # 3142760 belongs to bd saline flush 10ml syringe.The product 306559 was selected by the phone representative which is incorrect.Is there any patient involvement? if yes, what was the patient outcome? several patients had more than one attempt at iv insertion due to difficulty with flush.Was there any adverse event or serious injury reported? no.What medication/solution was being used during the incident? saline flush to clear the lines please confirm the quantity of defective syringes.N/a.Was the procedure completed as planned? yes, using saline flush with a different lot number was there any leakage inspected? no.Is sample available to be returned for investigation? if no, can a photo be provided? we have several boxes that we would like to return for credit/exchange.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there is resistance when pushing on the plunger.To aid in the investigation, ten samples in sealed packaging flow wraps were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.A device history record review was completed for provided material number 306546, lot 3142760.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.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.

• Brand Name: BD POSIFLUSH¿ SURESCRUB¿ SALINE SYRINGE
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17822161
• MDR Text Key: 324324819
• Report Number: 1911916-2023-00690
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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
• Report Date: 10/30/2023

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: 306546
• Device Lot Number: 3142760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/11/2023; 10/30/2023
• Supplement Dates FDA Received: 10/17/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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