MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 367336

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device type: jka, fpa.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.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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.

Event Description

It was reported that the bd vacutainer® push button blood collection set was involved in a dirty needle stick injury during use.The following information was provided by the initial reporter: material no.367336, batch no.Unknown.Clinician was drawing a venous blood gas with a syringe from the bd pbbcs.The clinician went to removed the luer adapter and tube holder after drawing blood tubes in-ordered to draw the venous blood gas into the syringe via the hub and just removed the tube holder and was stuck with the needle at the end of the luer adapter.

Manufacturer Narrative

Relevant tests/laboratory data: information received indicated that no actions were taken as a result of the issue.Therefore, it is understood that no medical intervention was therefore sought or received.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd vacutainer® push button blood collection set was involved in a dirty needle stick injury during use.The following information was provided by the initial reporter: material no.367336; batch no.Unknown.Clinician was drawing a venous blood gas with a syringe from the bd pbbcs.The clinician went to removed the luer adapter and tube holder after drawing blood tubes in-ordered to draw the venous blood gas into the syringe via the hub and just removed the tube holder and was stuck with the needle at the end of the luer adapter.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8748170
• MDR Text Key: 149639823
• Report Number: 2243072-2019-01289
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673365
• UDI-Public: 50382903673365
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• 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: 07/22/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367336
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other