MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS; PISTON SYRINGE

Catalog Number 304050

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 that barrel 1cc s/t w/sil no bd logo/tb bns had foreign matter.The following information was provided by the initial reporter: it was reported by the distributor, the doctors had a problem with the return of blood and difficulty performing their blood gas.The customer(s) is/are alleging an excessive amount of silicone in the barrel.Email verbatim: when the box was opened, the doctors had a problem with the return of blood and had great difficulty performing their blood gas.Based on the verbatim from field complaints it was not clear to our investigative team at the plant what the issue was with our syringe barrel.During our conference call on september 3rd the following was described to us.That the customer(s) is/are alleging an excessive amount of silicone in the 304050 barrel - which is having 2 effects: it is clogging your venting media which inhibits/prevents air from exiting your product (a pre-set arterial blood gas syringe) and therefore from filling with the correct amount of blood; and, excess silicone also migrates to the outside of the luer tip which causes the needle to disengage from the syringe.In this application, the plunger is set to a predetermined fill point, the stick is made and air is supposed to exit the syringe via the venting media (being forced out by the arterial pressure), and thereby filling the barrel interior to the pre-set plunger position.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the reported condition were received the reported defect could not be confirmed.A device history record review was completed for provided lot number 0286461.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported that barrel 1cc s/t w/sil no bd logo/tb bns had foreign matter.The following information was provided by the initial reporter: it was reported by the distributor, the doctors had a problem with the return of blood and difficulty performing their blood gas.The customer(s) is/are alleging an excessive amount of silicone in the barrel.Email verbatim: when the box was opened, the doctors had a problem with the return of blood and had great difficulty performing their blood gas.Based on the verbatim from field complaints it was not clear to our investigative team at the plant what the issue was with our syringe barrel.During our conference call on september 3rd the following was described to us.That the customer(s) is/are alleging an excessive amount of silicone in the 304050 barrel - which is having 2 effects: it is clogging your venting media which inhibits/prevents air from exiting your product (a pre-set arterial blood gas syringe) and therefore from filling with the correct amount of blood; and, excess silicone also migrates to the outside of the luer tip which causes the needle to disengage from the syringe.[in this application, the plunger is set to a predetermined fill point, the stick is made and air is supposed to exit the syringe via the venting media (being forced out by the arterial pressure), and thereby filling the barrel interior to the pre-set plunger position.].

• Brand Name: BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12554120
• MDR Text Key: 274572368
• Report Number: 1213809-2021-00682
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304050
• Device Lot Number: 0286461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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