MAUDE Adverse Event Report: BECTON DICKINSON, S.A. DISCARDIT II¿ SYRINGE W/NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 300330

Device Problems Crack (1135); Physical Resistance (2578); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

Event Description

It was reported that the discard it ii¿ syringe w/needle has difficulty drawing up medicine, the barrel of the syringe is cracked, once the drug is withdrawn, it is difficult to push, and drawing of blood needs to done with force which leads to hemolysis.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: no photos or samples were provided to investigate for this record.Unfortunately, as a result, the reported issue was not able to be verified.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100% the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.The syringe barrel could break because of some strong condition during handling or use of the product.Plastic material becomes brittle with low temperatures.However, the barrel will only crack if an excessive force is used.Bd can verify the syringes meets the product specs and recommended values in the product standards.The medication/drug used or a special method of use (high temperatures, pressures, several uses, etc.) could affect the sliding properties of the syringes.The probability of finding this kind of defect is an isolated issue and any recurrence is really unlikely in our products since review syringe dhr showed no indication of the alleged defect, considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no actions are required.Investigation conclusion: not possible to establish an accurate root cause.Possible irregular conditions of storage or use of the product after manufacture process.

Event Description

It was reported that the discardit ii¿ syringe w/needle has difficulty drawing up medicine, the barrel of the syringe is cracked, once the drug is withdrawn, it is difficult to push, and drawing of blood needs to done with force which leads to hemolysis.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: DISCARDIT II¿ SYRINGE W/NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7614678
• MDR Text Key: 112310894
• Report Number: 3002682307-2018-00149
• 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: 07/31/2018

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 300330
• Device Lot Number: 1701193
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other