MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB; PISTON SYRINGE

Catalog Number	305537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
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 foreign matter occurred with a syringe allergy 1 ml w/ndl 26x1/2 rb.The following information was provided by the initial reporter, "material no: 305537.Batch no: 8172744.It was reported that about 15% of needles have debris on them, and another syringe had a cracked plunger that broke off when drawing up serum.Per customer email: i am also sending back the needles with the issues.We have disposed of about 15% of our syringes today due to debris on the needle.We also had an issue with a cracked plunger today that broke off when we tried to draw up some serum.It is all the same lot.We are waiting on a new box and lot number from our distributer.There have been similar issues with other lots, but not to the extreme of the current lot.".
Additional Manufacturer Narrative
Investigation: customer returned (8) 1ml, 13mm, 26g bd allergy syringes in open trays from lot # 8172744.Customer states that t about 15% of needles have debris on them, and another syringe had a cracked plunger that broke off when drawing up serum.All returned syringes were examined and one sample exhibited a broken plunger.Also, 3 out of 8 samples exhibited strands of material on the cannula shaft.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The analysis shows that this material is most likely polyethylene mixed with silicone.A review of the device history record was completed for batch #8172744.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Possible root cause for the foreign matter: this fm likely represents what we call ¿angel hair¿.This is created when we move components from one line to another via the tube ¿pea shooters¿.This is a pressurized tubing transport system made of polyethylene plastic; as the components move through the pea shooters, occasionally small fragments of the plastic tube are stripped off and form this angel hair.In this case, it most likely found it¿s way into the shield and ultimately onto the cannula.There are various efforts within the plant to try and help reduce and hopefully eliminate this, however, it is an inherent portion of the process at this time.Probable root causes: for broken plungers: dry barrels (insufficient silicone) from the prep dial that result from a silicone gun not firing.Insufficient silicone leads to difficulty exercising the plunger, and can thereby result in broken plungers.Plunger screw jams that would damage plungers, i.E., they break plungers bowed plungers that do not get seated, and get broken off at the delrin wheel.
Event or Problem Description
It was reported that foreign matter occurred with a syringe allergy 1ml w/ndl 26x1/2 rb.The following information was provided by the initial reporter, "material no: 305537; batch no: 8172744.It was reported that about 15% of needles have debris on them, and another syringe had a cracked plunger that broke off when drawing up serum.Per customer email: i am also sending back the needles with the issues.We have disposed of about 15% of our syringes today due to debris on the needle.We also had an issue with a cracked plunger today that broke off when we tried to draw up some serum.It is all the same lot.We are waiting on a new box and lot number from our distributer.There have been similar issues with other lots, but not to the extreme of the current lot.".

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8562812
• Report Number: 1920898-2019-00400
• Device Sequence Number: 19406629
• Product Code: FMF
• UDI-Device Identifier: 30382903055372
• UDI-Public: 30382903055372
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 07/31/2023
• Device Catalogue Number: 305537
• Device Lot Number: 8172744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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