MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL; PISTON SYRINGE

Model Number 309695

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that at least one bd syringe control 10ml ll experienced a damaged plunger rod.The following information was provided by the initial reporter: the doctor was injecting local into the patient and as he was doing so the top ring of the control syringe slide off and snapped a part of the plunger, resulting in the syringe slipping and the needle sticking the dr.The nurse brought the syringe to me and explained that this particular issue has occurred several other times in the or, none resulting in injury.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

D10: device available for eval?: yes.Returned to manufacturer on: 2022-01-13.H3: device returned to manufacturer?: yes.H3: device eval by manufacturer?: yes.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d4: medical device lot #: 1238923; d4: medical device expiration date: 2026-08-31; h4: device manufacture date: 2021-08-26.D4: medical device lot #: 1146086; d4: medical device expiration date: 2026-05-31; h4: device manufacture date: 2021-05-26.D4: medical device lot #: 1200209; d4: medical device expiration date: 2026-07-31; h4: device manufacture date: 2021-07-19.H6: investigation summary: thirty-one 10ml control syringes sealed in blister packages (p/n 309695) were received.One sample was from batch #1146086, one sample was from batch #1200209, and twenty-nine from batch #1238923.The samples were force tested for thumb grip weld strength.Each sample was yielded acceptable results per product specification.Since the samples received did not display the reported condition a potential root cause could not be established and corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that at least one bd syringe control 10ml ll experienced a damaged plunger rod.The following information was provided by the initial reporter: the dr.Was injecting local into the patient and as he was doing so the top ring of the control syringe slide off and snapped a part of the plunger, resulting in the syringe slipping and the needle sticking the dr.The nurse brought the syringe to me and explained that this particular issue has occurred several other times in the or, none resulting in injury.

• Brand Name: BD SYRINGE CONTROL 10ML LL
• 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: 13101679
• MDR Text Key: 285365883
• Report Number: 1213809-2021-00824
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: 30382903096955
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309695
• Device Catalogue Number: 309695
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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