MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.

Event Description

Mat#: 306547; lot#: 3226389.It was reported by customer that difficult to push hard to get plunger to move and slow push once started.Verbatim: rcc received complaint via email.Email(s) attached.Reports from staff problems with bd prefilled flush syringes- lot number 3226389- ref/model 306547 exp.Dates 7-31-26.Very difficult to push hard to get plunger to move and slow push once started.Attempted to recreate many times and unable.Reported increase occlusion alarms on alaris syringe module in nicu again unable to recreate.Megan the nicu educator stated they have received multiple manufactures over past few months for prefilled syringes due to back orders they are told.None witnessed during day coverage.Nurses had just heard it happened on previous shift.Reported to go live support team during rounds.Allegedly some increase in alarms, reviewed syringes on unit with no success in recreating hard to plunge/push syringes.

Event Description

No additional information received  mat#: 306547 lot#: 3226389 it was reported by customer that difficult to push hard to get plunger to move and slow push once started.Verbatim: rcc received complaint via email.Reports from staff problems with bd prefilled flush syringes- lot number 3226389- ref / model 306547 exp.Dates 7-31-26.Very difficult to push hard to get plunger to move and slow push once started.Attempted to recreate many times and unable.Reported increase occlusion alarms on alaris syringe module in nicu again unable to recreate.(b)(6) the nicu educator stated they have received multiple manufactures over past few months for prefilled syringes due to back orders they are told.None witnessed during day coverage.Nurses had just heard it happened on previous shift.Reported to go live support team during rounds.Allegedly some increase in alarms, reviewed syringes on unit with no success in recreating hard to plunge/ push syringes.

Manufacturer Narrative

(b)(4) follow up report.A device history record review was completed by our quality engineer team for provided material number 306547 and lot number 3226389.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.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17894514
• MDR Text Key: 325377591
• Report Number: 1911916-2023-00749
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: 3226389
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1