MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ SYRINGES WITH NEEDLES LUER SLIP; SAFETY ENGINEERED SYRINGE AND NEEDLE

Catalog Number 990147

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone (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 in 10 bd¿ syringes with needles luer slip syringes that during use of the insulin preparation and application process, when removing the shield/protective cap the needle detached from the rest of the syringe."she also informs that due to this it was necessary to re-insert the needle.The client mentions that in the moment the insulin is applied in her mother, the insulin "explodes" between the junction of the needle and the syringe body.Note: the client is able to perform the aspiration of the insulin, but when performing the application, it identifies a pressure on the plunger, which assists in the occurrence of this "explosion" of insulin.Another problem identified was that among the 10 syringes, 2 of these got attached in the skin of their mother.The explosion of the insulin is related to its leakage through the syringe.The needle that separated and got attached to skin was removed by hands.¿ found during use.No serious injury or medical interventions needed.

Manufacturer Narrative

Investigation results: the sample provided was analyzed and it was not possible to confirm the defect.(separates - cannula - hub¿ / ¿leakage ¿ hub / difficult / unable to operate).The retention batch was checked and none was found clogged.Bd was not able to confirm/ reproduce the incident in question.The batch history analysis was performed, the quality notifications and maintenance records verified, and there is no quality notifications related with this batch.The batch complained was manufacturing during october 02nd 2017 to october 06th 2017.The inspections carried out on the sema01¿ semo01 ¿ semo02 ¿ seeb06 machine were checked and no records of this defect were found.The current controls for detecting this kind of failure is done by control plan.Qn/ maintenance review: there are no quality notification (qn) or maintenance report records that could lead to this issue for the batches involved in this complaint.Based on the severity and occurrence a capa is not required at this moment.Corrections are not applied, because the deviation cannot be confirmed.

• Brand Name: BD¿ SYRINGES WITH NEEDLES LUER SLIP
• Type of Device: SAFETY ENGINEERED SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7323655
• MDR Text Key: 102029181
• Report Number: 3003916417-2018-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K010188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 990147
• Device Lot Number: 7270801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other