MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

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.(b)(4).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 when using the unspecified bd needle there was non patient needle separation from the holder luer/adaptor/hub.The following information was provided by the initial reporter.The customer stated: "the needle broke off while in patients arm and caused harm such as "puffiness" and states area was hard.(b)(6) 2022 - patient fields updated: did erroneous results occur? no.If yes¿detailed erroneous results (include # of errors and type): n/a.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes¿detailed hazard including any medical intervention: per customer, needle detached from tube.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported when using the unspecified bd needle there was non patient needle separation from the holder luer/adaptor/hub.The following information was provided by the initial reporter.The customer stated: "the needle broke off while in patients arm and caused harm such as "puffiness" and states area was hard.Sun (b)(6) 10:10:50 utc 2022 - patient fields updated: did erroneous results occur? no.If yes¿detailed erroneous results (include # of errors and type): n/a.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes¿detailed hazard including any medical intervention: per customer, needle detached from tube.

• Brand Name: UNSPECIFIED BD NEEDLE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 15847918
• MDR Text Key: 307678690
• Report Number: 2243072-2022-02030
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/15/2022
• 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