MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 30ML ENTERAL S/C 56; GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number	302836
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a broken plunger was found before use with a syringe 30ml enteral s/c 56.The following information was provided by the initial reporter, "i would like to report an issue the nicu had over the weekend with the 30ml oral/enteral syringe ref 302836.They had several from their supply in which the plastic on the plunger was cracked.".
Additional Manufacturer Narrative
H.6.Investigation: one (1) sample was provided by the customer for investigation.The sample was returned in an opened blister pack.The returned sample was visually examined and it was observed that there is a crack in one of the plunger rod ribs.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Plunger rods are fed through a chute to the assembly process.If the chute is empty, the plunger rods can experience excessive force when falling through the entire chute.A sensor was installed on the chute to determine if the chute is empty.When the chute is full, the plunger rods do not slide the entire length of the chute and have a reduced risk of damage.The sensor will not allow plunger rods to automatically feed into the chute unless it is full.However; the plunger rods still experience piece to piece and piece to equipment contact while could result in damage.H3 other text : see h.10.
Event or Problem Description
It was reported that a broken plunger was found before use with a syringe 30ml enteral s/c 56.The following information was provided by the initial reporter, "i would like to report an issue the nicu had over the weekend with the 30ml oral/enteral syringe ref 302836.They had several from their supply in which the plastic on the plunger was cracked.".

• Brand Name: SYRINGE 30ML ENTERAL S/C 56
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8913381
• Report Number: 1911916-2019-00841
• Device Sequence Number: 1904356
• Product Code: KNT
• UDI-Device Identifier: 30382903028369
• UDI-Public: 30382903028369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 302836
• Device Lot Number: 8360699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other