MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; BLOOD COLLECTION SET, 23GX0.75"

Model Number DYNDTNBCS23G

Device Problem Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, when using a 23g blood collection set, the customer reported issues with the bevel being upside, down, tubing had a hole in it, safety lock not engaged right out of the package and the rubber sheath falling off.According to the customer contact, due to the "tubing having a hole in it" the patient had to be restuck.A sample of the same lot was returned and examined by the manufacturer, a definitive root cause could not be determined.There were no additional details provided in the report.It has been determined that the reported event caused or contributed to serious injury therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Tubing had a hole in it, causing blood to leak requiring an additional needle stick.

• Brand Name: Medline
• Type of Device: BLOOD COLLECTION SET, 23GX0.75"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16010297
• MDR Text Key: 305785523
• Report Number: 1417592-2022-00240
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DYNDTNBCS23G
• Device Catalogue Number: DYNDTNBCS23G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other