MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED 3ML SYRINGE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

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

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: 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.Medical device expiration date: unknown.Initial reporter phone #: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used based of user facility.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 that when attempting to administer medication into picc line the medication was leaking at the connector, and the safety was not locking securely with an unspecified 3ml syringe.The following information was provided by the initial reporter: it was reported that medication was leaking at connector when administering.When attempting to administer with another syringe the leaking occurred again and it was noticed that the syringe was not locking securely.

Manufacturer Narrative

Investigation: one sample is received for investigation, there is no catalog or lot number.Sample is tested for leakage, after the results obtained, there were no leakage problems, this indicates that the manufactured product complies with the internal quality standards that guarantee its functionality.The defect was not confirmed and the root cause could not be determined.At this time, no corrective actions are necessary.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that when attempting to administer medication into picc line the medication was leaking at the connector, and the safety was not locking securely with an unspecified 3ml syringe.The following information was provided by the initial reporter: it was reported that medication was leaking at connector when administering.When attempting to administer with another syringe the leaking occurred again and it was noticed that the syringe was not locking securely.

• Brand Name: UNSPECIFIED 3ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9197966
• MDR Text Key: 176052068
• Report Number: 2243072-2019-02318
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: 09/03/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 DA