MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. GLASS LOSS-OF-RESISTANCE SYRINGE

Model Number GLR10MS

Device Problems Hole In Material (1293); Device Packaging Compromised (2916)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).A total of two (2) unused, unopened samples, in packaging indicating the reported lot number 0061376564, were returned for evaluation.Upon visual observation: sample # 1 -- two small tears/puncture marks were observed in the white tyvek backing of the pouch.The tears corresponded with each end of the enclosed syringe.Sample # 2 -- one small tear/puncture mark was observed in the white tyvek backing of the pouch.The tear corresponded with the plunger end of the enclosed syringe.Based on the results of this investigation, it could not be definitively determined where in the packaging/shipping/handling process this issue occurred.While no specific conclusions could be drawn, it should be noted that although our packaging is tested to astm standards during development to ensure that they will maintain integrity under normal to strenuous shipping conditions, excessive handling may result in some damage.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: event # 2: reports two packages were found with holes in the package.The outer case did not appear damaged.

• Brand Name: GLASS LOSS-OF-RESISTANCE SYRINGE
• Type of Device: GLASS LOSS-OF-RESISTANCE SYRINGE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5733156
• MDR Text Key: 48404393
• Report Number: 2523676-2016-00372
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: GLR10MS
• Device Catalogue Number: 332158
• Device Lot Number: 0061376564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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