MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,; PISTON SYRINGE

Model Number 309659

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown device manufacture date: unknown.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¿ luer slip tip syringe sterile, single use a clog causes leakage from the side.There was no report of patient impact.The following information was provided by the initial reporter: we just received another complaint from on (b)(6) 2022 for two of the needles.They have had too many with issues that are either so resistant no solution will come out or the solution comes out the side.That might be why the solution came out the side on the one due to whatever is blocking the tip of the needle.

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported while using bd¿ luer slip tip syringe sterile, single use a clog causes leakage from the side.There was no report of patient impact.The following information was provided by the initial reporter: we just received another complaint from on 10/5/22 for two of the needles.They have had too many with issues that are either so resistant no solution will come out or the solution comes out the side.That might be why the solution came out the side on the one due to whatever is blocking the tip of the needle.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15704232
• MDR Text Key: 306894328
• Report Number: 1213809-2022-00844
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: 30382903096597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• 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
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309659
• Device Catalogue Number: 309659
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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