MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 3ML LUER-LOK SYRINGE

Catalog Number 990174

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 a crack occurred with a bd plastipak¿ 3ml luer-lok¿ syringe.The following information was provided by the initial reporter, "customer reports: "when collecting a blood test, i realize that 3ml syringe of the bd brand (lot 8269868 fab 10/2018) was cracked and leaked the blood collected, at the same time i do the material exchange." information received by email on 4/25/2019: the health professional used the scalp with help of the syringe to perform the collect of the patient's blood and noticed that the blood flowed from the external side of the syringe.They change the syringe and finish the collect in the same punction.So there was no damage to the patient or health professional.".

Event Description

It was reported that a crack occurred with a bd plastipak¿ 3ml luer-lok¿ syringe.The following information was provided by the initial reporter, "customer reports: "when collecting a blood test, i realize that 3ml syringe of the bd brand (lot 8269868 fab 10/2018) was cracked and leaked the blood collected, at the same time i do the material exchange." information received by email on 4/25/2019: the health professional used the scalp with help of the syringe to perform the collect of the patient's blood and noticed that the blood flowed from the external side of the syringe.They change the syringe and finish the collect in the same punction.So there was no damage to the patient or health professional.".

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample sent by the customer was verified and it was possible to observe barrel cracked.The potential cause for the occurrence is a failure at syringe assembly station, which caused the barrel cracked at another syringes.The incident identified from this complaint will be monitored for trend evaluation.

• Brand Name: BD PLASTIPAK 3ML LUER-LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8595863
• MDR Text Key: 146516448
• Report Number: 3003916417-2019-00235
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000347
• UDI-Public: 7891463000347
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 990174
• Device Lot Number: 8269868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other