MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305272

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the detachable needle in the bd integra¿ syringe was loose and failed to completely retract.The following information was provided by the initial reporter: "we've received a few reports of faulty needle retraction with the bd integra syringe (3 ml 22g x 1 ½).Affected lot# 1029959, exp 2026-01-31.Per reports, we've heard of the needles falling out, of needles not fully retracting, and others where it seems to be functioning as intended.".

Event Description

It was reported that 25 detachable needle in the bd integra¿ syringe were loose and failed to completely retract.The following information was provided by the initial reporter: "we've received a few reports of faulty needle retraction with the bd integra syringe (3 ml 22g x 1 ½).Affected lot# 1029959, exp 2026-01-31.Per reports, we've heard of the needles falling out, of needles not fully retracting, and others where it seems to be functioning as intended.".

Manufacturer Narrative

The following field was updated due to additional information: b.5.Describe event or problem: it was reported that 25 detachable needle in the bd integra¿ syringe were loose and failed to completely retract.The following information was provided by the initial reporter: "we've received a few reports of faulty needle retraction with the bd integra syringe (3 ml 22g x 1 ½).Affected lot# 1029959, exp 2026-01-31.Per reports, we've heard of the needles falling out, of needles not fully retracting, and others where it seems to be functioning as intended.".H.6.Investigation: one photo was received and evaluated.The photo showed the graphic side of a 3ml integra syringe package (material 305272).The variable information was not visible due to the quality of the photo.There were no visible defects present in the photo.A physical sample is needed for a more complete evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12125489
• MDR Text Key: 260283870
• Report Number: 1213809-2021-00472
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: 1029959
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1