MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 an unspecified bd syringe the plunger fell out.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: we continue to see issues in one area of our hospital (all different staff involved) and the plunger is removed when the tamper packaging is opened.Education/videos/rounds have been completed as well, re: properly opening the packaging.(b)(6) 2023: -could you please advise the occurrence date? (b)(6) 2023.-what is the material and batch number of the affected product? unsure.-is there any adverse event on patient? no.-do you have photo of the faulty product? no.-is sample available for return? if yes, please provide address for return label.No.-i do not have any batch numbers.

Event Description

It was reported while using an unspecified bd syringe the plunger fell out.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: we continue to see issues in one area of our hospital (all different staff involved)and the plunger is removed when the tamper packaging is opened.Education/videos/rounds have been completed as well, re: properly opening the packaging.15 aug 23 -could you please advise the occurrence date? 4/24/23, 5/2/23, 6/16/23, 6/20/23, 6/29/23, 7/27/23 -what is the material and batch number of the affected product? unsure-@xxxx? -is there any adverse event on patient? no -do you have photo of the faulty product? no -is sample available for return? if yes, please provide address for return label.No -i do not have any batch numbers.

Manufacturer Narrative

H6: investigation summary as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17597744
• MDR Text Key: 321681531
• Report Number: 2243072-2023-01487
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 08/29/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/14/2023
• 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