MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPACK¿ SYRINGE; HYPODERMIC SYRINGE

Catalog Number 990172

Device Problems Material Rupture (1546); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: a sample or photo is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that when detaching the bd plastipack¿ syringe(s), the plastic blister ruptures contaminating the entire "ow of syringes.There was no report of injury or medical interventions.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• 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: 7269855
• MDR Text Key: 100145003
• Report Number: 3003916417-2018-00012
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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