MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE

Catalog Number 302558

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Three potential lot numbers were provided for this incident.The information for each lot number is as follows:  medical device lot #: 7137557, medical device expiration date: 2022-04-30,  device manufacture date: 2017-07-04.Medical device lot #: 7137559, medical device expiration date: 2022-04-30,  device manufacture date: 2017-07-07.Medical device lot #: 8016550, medical device expiration date: 2022-12-31, device manufacture date: 2018-02-27.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using 10ml bd plastipak¿ syringes, there was leakage reported in the body of the syringes.Blood splashed on the face and clothes of the nursing staff and on several patients.There was no report of direct exposure to mucous membranes, serious injury or medical intervention.

Manufacturer Narrative

Describe event or problem: the initial mdr did not describe the event correctly.Investigation summary: photos received at bd for investigation for lot number 7137557 and 7137559.Samples were visually evaluated.Dimensional evaluations of the components of the syringe (plunger, barrel and stopper) were also evaluated.A cracked barrel is observed, therefore defect is confirmed.Additionally, a photo was received for lot number 8135550.A slightly inclined cannula is observed, however a cracked barrel is not observed.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.Possible root cause for the defect is occurrence within the process, the dial where the assembly is made may be causing damage to the syringe, however there is a sensor to eject the syringes when they are not well assembled but its functionality has not been 100% effective.Corrective actions include improvements to the assembly line team, as well as staff qualification.In addition, a corrective and preventative action #(b)(4) was generated to follow up on failure modes identified and their respective action plan, given the event of leakage to investigate the defect on this machine.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 while using 10ml bd plastipak¿ syringes, there was leakage reported in the body of the syringes.Blood splashed on the face and clothes of the nursing staff and on several patients.There was no report of medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7508674
• MDR Text Key: 108093513
• Report Number: 9614033-2018-00023
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 302558
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 07/17/2018
• 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
• Patient Outcome(s): Other