MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Overdose (1988)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a lot number could not be confirmed for this incident, and without this information we are unable to determine where the device was manufactured.(b)(4).Initial reporter: the customer's address is unknown:  (b)(6), usa has been used as a default.  device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

T was reported that during use of an unspecified bd syringe, the patient received multiple incorrect doses of gentamicin and heparin resulting in a serious injury.The following information was provided by the initial reporter, "a pediatric pt at our hosp unintentionally received multiple 5ml doses of antibiotic locks (gentamicin 1mg/ml and heparin 2500 units/ml).These were intended to be used as locks for cvc lines, where the priming volume for the cvc lines would be instilled, dwell for a few hours and then be withdrawn prior to the next lock administration.The order did not specify a dwell volume for the cvc lines.The above concentration for gentamicin lock with heparin was used based on idsa guidelines.Pt experienced bleeding episodes from several locations and it was later identified that the gentamicin-heparin locks were the likely cause for the bleeding.Symptoms were resolved after the gentamicin-heparin locks were discontinued.Perception of antibiotic lock terminology by pharmacy and nursing was found to be different.The nursing team aspirated 5ml from the line before each antibiotic lock administration, and then flushed the new lock through the line after the specified dwell time.There was no pre-built order on epic for this specific lock and hence it was entered using unlisted pathway which has limitations on specifying the actual drug dose, in this case priming volume for the cvc line.Although administration instructions stated to instill and withdraw after the dwell time, having no dose (priming volume) specified on the order/label let to the administration of the whole contents of the syringe, 5ml.Our improvement actions included house-wide education on antibiotic locks, development of an order set for antibiotic locks, where the priming volume is a hard stop for the providers, development of a policy and also customizing all unlisted iv medications with a hard stop that requires the provider to consult with both the pharmacist and nurse to release the order.Bd prefilled heparin flushes - the name "heparin lock flush" contributed to some confusion on terminology of "lock" vs "flush".Pt counseling provided.".

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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

T was reported that during use of an unspecified bd syringe, the patient received multiple incorrect doses of gentamicin and heparin resulting in a serious injury.The following information was provided by the initial reporter."a pediatric pt at our hosp unintentionally received multiple 5ml doses of antibiotic locks (getamicin 1mg/ml and heparin 2500 units/ml).These were intended to be used as locks for cvc lines, where the priming volume for the cvc lines would be instilled, dwell for a few hours and then be withdrawn prior to the next lock administration.The order did not specify a dwell volume for the cvc lines.The above concentration for gentamicin lock with heparin was used based on idsa guidelines.Pt experienced bleeding episodes from several locations and it was later identified that the gentamicin-heparin locks were the likely cause for the bleeding.Symptoms were resolved after the gentamicin-heparin locks were discontinued.Perception of antibiotic lock terminology by pharmacy and nursing was found to be different.The nursing team aspirated 5ml from the line before each antibiotic lock administration, and then flushed the new lock through the line after the specified dwell time.There was no pre-built order on epic for this specific lock and hence it was entered using unlisted pathway which has limitations on specifying the actual drug dose, in this case priming volume for the cvc line.Although administration instructions stated to instill and withdraw after the dwell time, having no dose (priming volume) specified on the order/label let to the administration of the whole contents of the syringe, 5ml.Our improvement actions included house-wide education on antibiotic locks, development of an order set for antibiotic locks, where the priming volume is a hard stop for the providers, development of a policy and also customizing all unlisted iv medications with a hard stop that requires the provider to consult with both the pharmacist and nurse to release the order.Bd prefilled heparin flushes - the name "heparin lock flush" contributed to some confusion on terminology of "lock" vs "flush".Pt counseling provided.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8876404
• MDR Text Key: 153882426
• Report Number: 2243072-2019-01647
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention