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

Catalog Number UNKNOWN

Device Problems Short Fill (1575); Defective Component (2292)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Initial reporter city: since the city is unknown, nj will be used as its place holder until further updated by the customer.Initial reporter country : unknown united states was used until further updated.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the unspecified bd arterial blood collection syringe, the device experienced insufficient blood flow through device via difficult plunger movement.Magnesium sulfate compresses were applied.Report of adverse event with gas syringe.Female (b)(6), number 1: newborn with a diagnosis of tpn at 35 weeks with adequate weight for gestational age, respiratory distress syndrome with oxygen requirement for nasal cpap, with indication to take arterial blood gases for admission and control, who was punctured repeatedly due to difficult obtaining a sample since the syringe does not allow the blood to return more than 1cc.Patient with ecchymosis at puncture sites to whom magnesium sulfate compresses were applied.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.H3 other text : see h10.

Event Description

It was reported when using the unspecified bd arterial blood collection syringe, the device experienced insufficient blood flow through device via difficult plunger movement.Magnesium sulfate compresses were applied.Report of adverse event with gas syringe.Female newborn, number 1: newborn with a diagnosis of tpn at 35 weeks with adequate weight for gestational age, respiratory distress syndrome with oxygen requirement for nasal cpap, with indication to take arterial blood gases for admission and control, who was punctured repeatedly due to difficult obtaining a sample since the syringe does not allow the blood to return more than 1cc.Patient with ecchymosis at puncture sites to whom magnesium sulfate compresses were applied.

• Brand Name: UNSPECIFIED BD ARTERIAL BLOOD COLLECTION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13090783
• MDR Text Key: 286256689
• Report Number: 2243072-2021-02979
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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
• Date Manufacturer Received: 12/28/2021
• 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 Sex: Female