MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Packaging Problem (3007)

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

Event Date 03/12/2021

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 franklin lakes 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.The customer's address is (b)(6) has been used as a placeholder based on the reported phone area code.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 the unspecified bd q-syte¿ device packaging was found open before use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "it was reported via survey response that the clinician experienced particulate embolism (3), leakage (1), bd q-syte septum is damaged/defective (1), unable to break seal (3), package open (1).Additional info related to what leaked and from where states: "antibiotics" " the seal" additional info related to bd q-syte septum is damaged/defective states: "package open, plastic chipped"".

Manufacturer Narrative

H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

Event Description

It was reported that the unspecified bd q-syte¿ device packaging was found open before use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "it was reported via survey response that the clinician experienced particulate embolism (3), leakage (1), bd q-syte septum is damaged/defective (1), unable to break seal (3), package open (1).Additional info related to what leaked and from where states: "antibiotics" " the seal".Additional info related to bd q-syte septum is damaged/defective states: "package open, plastic chipped".

• Brand Name: UNSPECIFIED BD Q-SYTE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11646104
• MDR Text Key: 247256475
• Report Number: 2243072-2021-01069
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1