MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II¿ SYRINGE

Catalog Number 301285

Device Problems Crack (1135); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Hemolysis (1886)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The manufacturing location for this product is (b)(6).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that the bd discardit ii¿ syringe was difficult when drawing up medicine.The barrel of the bd syringe are often cracked and become loose causing a wastage of drugs.Once the drug is withdrawn it is often difficult to push.When drawing the blood, it is done with such force that often leads to hemolysis.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Our quality engineer was unable to verify the reported complaint.No samples or pictures were provided.The device history review found no non-conformities.The team reviewed assembly & packaging process and all process controls are found in place.In process inspection and quality check, no crack samples had been found.Also, a machine has an online facility to check crack barrel and challenge test conducted in every shift.For the issue difficulty in plunger movement as claimed; the sustaining and separation forces for barrel and plunger were measured during the manufacturing of lot# 17g2811, all forces were found within the specification limit.There is chance of the product becoming damaged during transportation & storage after dispatch.The unit package of product might have got collapsed and pressed due to impact force of some other material stored above causing stress/pressure on barrel and resulting in crack on syringe.Due to non-availability of actual defective sample, further investigation could not be initiated.The exact root cause is not identified.

Event Description

It was reported that the bd discardit ii syringe was difficult when drawing up medicine.The barrel of the bd syringe are often cracked and become loose causing a wastage of drugs.Once the drug is withdrawn it is often difficult to push.When drawing the blood, it is done with such force that often leads to hemolysis.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD DISCARDIT II¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7616540
• MDR Text Key: 111991200
• Report Number: 2243072-2018-00406
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301285
• Device Lot Number: 17G2811
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other