MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD 60CC PISTON IRRIGATION SYRINGE, INDIVIDUALLY SEALED WITH SYRINGE AND CAP, S; PISTON SYRINGE

Catalog Number	750375
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
Event or Problem Description
It was reported that the piston syringe leaked.
Event or Problem Description
It was reported that the piston syringe leaked.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted five total syringes.Three syringes (syringes #1-3) were returned within sealed original packaging.One syringe (syringe #4) was returned in an unsealed original packaging, and the last syringe (syringe #5) was returned in no original packaging.None of the syringes appeared to be used.The words "no good" were written on the returned packages.All syringes were removed from the packaging and inspected.Visual inspection of the syringes surfaces noted no obvious visible defects.Each syringe was filled with 50ml of a methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).No leaks were immediately noted from any of the syringes.Syringes were allowed to rest for 15 minutes.A finger was placed over the tapered opening and pressure was applied to the plunger.Leaks were visible from all five syringes.Dimensions of all five syringes were measured and found to be within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿bard® custom select 70cc piston syringe single use only.Sterile unless package is opened or damaged.Do not use if package is opened or damaged.Intended use: integral catheter tip - for catheter irrigation caution: secure tip tightly prior to use.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physican.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.© 2005 c.R.Bard, inc.All rights reserved.¿.

• Brand Name: BARD 60CC PISTON IRRIGATION SYRINGE, INDIVIDUALLY SEALED WITH SYRINGE AND CAP, S
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7605278
• Report Number: 1018233-2018-02259
• Device Sequence Number: 19230074
• Product Code: KYZ
• UDI-Device Identifier: 00801741051142
• UDI-Public: (01)00801741051142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 750375
• Device Lot Number: NGCN2039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 05/26/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1