MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA NEEDLE PRECISIONGLIDE 19X1IN; SYRINGE AND NEEDLE

Catalog Number 300029

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/09/2019

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 an unspecified number of needle precisionglide 19x1in experienced foreign matter contamination in the fluid path.The following information was provided by the initial reporter: when opening the package of the 19g x 1 bd needle it was noticed a dirt on the plastic hub.Information received by email on 4/17/2019: the incident was noticed before the use.There was no damage to the patient/health professional.

Event Description

It was reported that an unspecified number of needle precisionglide 19x1in experienced foreign matter contamination in the fluid path.The following information was provided by the initial reporter: when opening the package of the 19g x 1 bd needle it was noticed a dirt on the plastic hub.Information received by email on 4/17/2019: the incident was noticed before the use.There was no damage to the patient/health professional.

Manufacturer Narrative

Investigation: batch history analysis (dhr), maintenance records and quality notifications were verified, no quality deviations occurred only one maintenance record was detected.We received the picture sent by the client for evaluation, so it was possible to carry out an investigation, confirm the complaint for the defect and determine the probable root cause.The foreign matter occurred due to one machine cleanness packing machine after maintenance.Fm was oil.For this kind of failure one blitz was raised to avoid new occurrences.

• Brand Name: NEEDLE PRECISIONGLIDE 19X1IN
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8557398
• MDR Text Key: 146514871
• Report Number: 3003916417-2019-00214
• 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
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 300029
• Device Lot Number: 8318695
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other