MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS CONTAINER

Catalog Number 303205

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

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, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a needle pierced through the wall of the bd¿ sharps collector, and the staff member sustained a dirty needle stick injury as a result.Blood testing for hiv, hep b and c were completed for both the staff member and the source patient, but the results of the testing were not reported.The following information was provided by the initial reporter: 24g needle pierced through side of the blood collection device at a patient bed space in pacu ward.Staff member sustained a blood and body fluid exposure when sharps container was being removed from the bracket.Hcp needed to be tested for hiv, hep b and hep c.Patient sourced and tested for hiv, hep b and hep c.24 hour wait for the staff member for results and potential need for viral prophylaxis.

Event Description

It was reported that a needle pierced through the wall of the bd¿ sharps collector, and the staff member sustained a dirty needle stick injury as a result.Blood testing for hiv, hep b and c were completed for both the staff member and the source patient, but the results of the testing were not reported.The following information was provided by the initial reporter: "24g needle pierced through side of the blood collection device at a patient bed space in pacu ward.Staff member sustained a blood and body fluid exposure when sharps container was being removed from the bracket.Hcp needed to be tested for hiv, hep b and hep c.Patient sourced and tested for hiv, hep b and hep c.24 hour wait for the staff member for results and potential need for viral prophylaxis.".

Manufacturer Narrative

H6: investigation summary: no product was returned by the customer.Photos representation was provided for the complaint.It was reported by the customer that 24g needle pierced through side of the blood collection device at a patient bed space in pacu ward.Staff member sustained a blood and body fluid exposure when sharps container was being removed from the bracket was unable to verified because actual complaint container is no longer available and the batch label scratched out (white label) it will not be possible for manufacturer to investigate the actual container batch interim investigation from the past 6 months of production, and all containers are meeting the minimum wall thickness of 1.2mm as per specification.Verify current 1.4l sharps with evidence for wall thickness current production meets wall thickness specification.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS CONTAINER
• 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: 15332908
• MDR Text Key: 299043244
• Report Number: 2243072-2022-01443
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• 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 Outcome(s): Required Intervention