MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PREFILLED HEPARIN SYRINGE; PRE-FILLED SYRINGE

Catalog Number UNKNOWN

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no: unknown, batch no: unknown.It was reported that after use of the unspecified bd¿ prefilled heparin syringe marcescens was not found in any cultures from any prefilled heparin flushes, but bacillus ssp were identified from several different lots.Three patients were admitted to the pediatric intensive care unit.The following information was provided by the initial reporter: in the article, they tested 165 syringes and had 9 cultures for bacillus.Three patients were admitted to the pediatric intensive care unit.

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident and a root cause could not be determined.A device history review could not be completed as no batch number was provided.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

Material no: unknown batch no: unknown it was reported that after use of the unspecified bd¿ prefilled heparin syringe marcescens was not found in any cultures from any prefilled heparin flushes, but bacillus ssp were identified from several different lots.The following information was provided by the initial reporter: in the article, they tested 165 syringes and had 9 cultures for bacillus.

Event Description

Material no: unknown; batch no: unknown.It was reported that after use of the unspecified bd¿ prefilled heparin syringe marcescens was not found in any cultures from any prefilled heparin flushes, but bacillus ssp were identified from several different lots.The following information was provided by the initial reporter: in the article, they tested 165 syringes and had 9 cultures for bacillus.

Manufacturer Narrative

B.5.Describe event or problem: material no: unknown; batch no: unknown.It was reported that after use of the unspecified bd¿ prefilled heparin syringe marcescens was not found in any cultures from any prefilled heparin flushes, but bacillus ssp were identified from several different lots.The following information was provided by the initial reporter: in the article, they tested 165 syringes and had 9 cultures for bacillus.H3 other text : see section h.10.

• Brand Name: UNSPECIFIED BD¿ PREFILLED HEPARIN SYRINGE
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8918034
• MDR Text Key: 158862886
• Report Number: 2243072-2019-01788
• Device Sequence Number: 1
• Product Code: NZW
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 08/02/2019
• Supplement Dates FDA Received: 08/23/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention